Category Archives: Regenerative Medicine

Published: Oct. 27, 2021 at 3:30 AM CDT|Updated: 21 hours ago

FRANKFURT, Germany, Oct. 27, 2021 /PRNewswire/ European Wellness Academy (EWA), the educational arm of European Wellness Biomedical Group (EWG), has signed an agreement to carry out joint scientific research on the efficacy of peptides, cell therapy, exosomes and cell reprogramming for rejuvenation in premature murine aging models.

EWA was represented by its Group Chairman, Prof. Dr. Mike Chan, while Heidelberg University was represented by its Commercial Managing Director, Katrin Erk and its Head of Institute of Anatomy and Cell Biology III, Prof. Dr. Thomas Skutella.

The cutting-edge therapeutics used for the studies include precursor (progenitor) stem cells (PSC), precursor cells (Frozen Organo Crygenics (FOC)), Mito Organelle (MO), Nano Organo Peptides (NOP) and exosomes.

Their studies include in vitro experiments concentrating on the effects of the products on the aging of somatic cells and cellular senescence, which is known to contribute to disease onset and progression. Investigated exosomes include neuronal stem cells (NSCs), mesenchymal stem cells (MSCs), cardiomyocytes, kidney progenitors and hepatocytes.

EWA and Heidelberg University will also conduct in vivo experiments to demonstrate both safety and efficacy of the therapeutics, whereby the proof of effectivity will be recorded in the life span, histopathological and molecular criteria of neurodegeneration including Alzheimer/dementia, and system degeneration disorders including those affecting the immune system, skin, cardio, lung, kidney, liver, stomach/intestine/gut, eye, and muscular dystrophy.

Other criteria included are cartilage/joint/bone regeneration including knees/joints/hips, cervical, thoracic, lumbar, pelvic and musculoskeletal disorder, as well as endocrine disorders like endocrinal dysfunction due to over and underproduction of hormones and other activity pattern under the sleep wake cycle.

The ongoing specially designed studies are coordinated and designed by Prof. Dr. Thomas Skutella of Heidelberg University, a world-renowned research university and one of Germany's Top 3, Prof. Dr.Mike Chan and scientists of EWG.

European Wellness Academy

Located in Germany, Switzerland, Greece and Malaysia, EWA is a UK CPD authorised body with a premium training and development wing that revolves around cutting-edge Bio-Regenerative Medicine modalities for practitioners and researchers. The Academy has extensive years of combined clinical experience and a core academic team comprising of qualified clinicians and scientists with multiple international affiliations and accreditations.

https://ewacademy.euhttps://european-wellness.eu/

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European Wellness Collaborates with Heidelberg University Germany to Conduct Efficacy Studies of Peptides and Cell Therapy Research - WTOK

The global Cell-Based Regenerative Medicine market is anticipated to observe noteworthy growth in the upcoming years. Growing need for businesses to examine areas of commotion, the extent of disruption, and fortify contingency planning to boost business continuity in the future years is driving the growth of the market.

As per a recent survey by insightSLICE, The globalCell-Based Regenerative Medicinemarket research report by therapy, applications and economic forecasts, company profiles and global, regional and country industry overviews.

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Competitive Landscape

Some of the major players in the Cell-Based Regenerative Medicine market are Acelity (KCI Concepts),Cook Biotech Inc., Organogenesis Inc.,Vericel Corporation, Osiris Therapeutics, Inc., andNuVasive, Inc.,Medtronic,Stryker Corporation,Integra LifeSciences, and C.R. Bard.

Segmentation Overview:

By Therapy:immunotherapy, cell therapy, tissue engineering, and gene therapy

By Applications:oncology, orthopedic & musculoskeletal disorders, dermatology, and cardiology

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TheCell-Based Regenerative Medicine Reportprovides industry professionals and strategists, corporate analysts, associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on the healthcare market.

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insightSLICE is a market intelligence and strategy consulting company. The company provides tailor-made and off the shelf market research studies. The prime focus of the company is on strategy consulting to provide end-to-end solutions.

Media ContactCompany Name: insightSLICEContact Person: AlexEmail: Send EmailPhone: +1 (707) 736 6633Country: United StatesWebsite: https://www.insightslice.com/cell-based-regenerative-medicine-market

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Cell-Based Regenerative Medicine Market Growth, Size, Share, Trends, COVID-19 Impact Analysis, and Forecasts to 2031 - Digital Journal

Small (or short) interfering RNA (siRNA) is the predominant RNA interference (RNAi) tool used for instigating short-term silencing of protein-coding genes. Simply put, these are naturally occurring molecules that silence genes that encode specific proteins.

Image Credit: Love Employee/Shutterstock.com

This means that siRNA demonstrates significant potential for therapeutic use, given its capacity to control protein levels. However, one of the main drawbacks with siRNA is that researchers have had difficulty transmitting the molecules to the site of action in the body, the cytosol target of cells, as a result of the bodys immune response.1

To overcome the challenges associated with siRNA delivery, a team of researchers in the Netherlands has been working to develop hybrid nanoparticles that protect and transmit siRNA into target cells.

The system the team is using relies on a combination of liposomes and extracellular vesicles (EVs), which offer unique properties that package and protect siRNA against enzyme degradation.

The hybrid nanoparticles have a hydrophobic coating, thanks to the amphiphilic nature of the liposomes, which provides adequate shielding against the bodys immune response. Additionally, as EVs can easily pass through the outer membrane of a cell, the siRNA can be delivered to the site of action as intended.

The method employed by the researchers uses a dehydration technique to produce a thin lipid film which can then be rehydrated in a water-based mixture containing the EVs and siRNA. This then generates the liposome-EV-siRNA hybrid nanoparticles, which allows for a target-based delivery system.

We show that with increasing relativeEV content in our hybrids, uptake into cells becomes no longer dictated by the liposome content ... Thus, the EV surface molecules now seem to dictate which cells can internalize and process these hybrids.

Pieter Vader, Lead Researcher and Professor of Experimental Cardiology and Regenerative Medicine at the University of Utrecht

By modifying the hybrid formulation and experimenting with the liposome to EV ratio, the researchers found that it was possible to choose into which cells the siRNA would take. The team also discovered that various cell types had the capacity to receive the hybrid nanoparticles without a toxic or adverse reaction this included kidney, nerve and ovarian cell types.

The ability to alter the ratio of the liposome-EV-siRNA formulation is important in designing cell-targeting drugs as it potentially means that only diseased cell types would be targeted, reducing any risk or undesirable side-effects.

Thus, hybrid nanoparticles could integrate the functional properties of both liposomes and EVs and offer a best of both worlds particle for the therapeutic delivery of siRNA.1

The team also looked at the therapeutic outcome when the hybrid formulation was induced with EVs from a specific stem cell population: the results remarkably demonstrated recovery and healing in breast cancer cells. This shows great promise for the future of drug development, especially when designing new drugs that target cancer and degenerative diseases.

While the results of this study make significant strides for the use of hybrid nanoparticles in siRNA delivery, Vader and his team have some way to go before this treatment technology will be rolled out commercially.

Its too soon to tell where the most potential lies for our delivery system, but we know that EVs derived from progenitor cells have intrinsic regenerative properties ... Thus, regenerative medicine applications seem most logical.

Pieter Vader, Lead Researcher and Professor of Experimental Cardiology and Regenerative Medicine at the University of Utrecht

Despite being some way off commercial viability, this recent study clearly demonstrates future potential for using hybrid nanotechnology for effective drug delivery to treat various cancers and other difficult-to-treat, degenerative diseases.

Continue reading: Manifesting Multidisciplinary Nanomedicine Research with the Multiscale Metrology Suite

Evers, M., Et. Al. (2021) Functional siRNA Delivery by Extracellular VesicleLiposome Hybrid Nanoparticles.Advanced Healthcare Materials, Available at: https://doi.org/10.1002/adhm.202101202

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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Using Hybrid Nanoparticles to Deliver siRNA to Different Cell Types - AZoNano

5.2 Importance of DPSCs in personalized regenerative medicine

Regenerative medicine has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to normalize congenital defects. Regenerative medicine substitutes for or regenerates damaged human cells, tissues and/or organs in order to restore their normal functioning [11]. Tissue engineering is an integral part of modern regenerative medicine. Tissue engineering involves the application of adult and/or stem cells, usage of cellular regeneration enhancing scaffolds and microenvironments, and important bioactive molecules and growth factors [12,13]. The success of tissue engineering and cellular regeneration is dependent on the biocompatibility of the scaffolds/molecules used, management of immune rejection and chronic inflammation and control of bacterial infections [13,14]. Recently, Dental Stem Cells (DSCs) are gaining more attention as a stem cell source in regenerative medicine due to its higher clonality, proliferation potential and the capacity to retain stemness even after long-term cryopreservation [15]. Several studies have provided evidence that human dental pulp contains precursor cells, named dental pulp stem cells (hDPSC). These cells have self-renewal potential and multilineage differentiation capacity. As these cell cells can be easily isolated, cultured and cryopreserved, they form an attractive stem cell source for futuristic tissue engineering purposes [16].

Dental Stem Cells (DSCs) are mesenchymal cell populations that exhibit self-renewal capacity and multidifferentiation potential [17,18]. As mentioned earlier, Dental Pulp Stem Cells (DPSCs) are the first identified and characterized DSCs [2]. Currently, there are five main types of DSCs [19,20]. They are: stem cells from exfoliated deciduous teeth (SHED) [3], periodontal ligament stem cells (PDLSCs) [21], and dental follicle precursor cells (DFPCs) [22], stem cells from apical papilla (SCAP) [23]. All these stem cells except SHED are capable of forming permanent teeth [19]. Since these cells are easily accessible, and they prevail throughout the lifetime of human beings, they are widely studied in regenerative medicine as a source of autologous stem cells. These cells find applications in regenerative therapies including oro-facial, neurologic, ocular, cardiovascular, diabetic, renal, muscular dystrophy and autoimmune conditions [19,20]. In this chapter, we aim to highlight the recent developments and findings in the field of DPSC mediated regenerative medicine. Indeed, DPSCs can be used for clinical applications in a wide array of diseases. But, only the most relevant findings with regards to regenerative medicine associated with DPSCs is discussed in the current chapter.

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Regenerative Medicine - an overview | ScienceDirect Topics

Abstract

Organ and tissue loss through disease and injury motivate the development of therapies that can regenerate tissues and decrease reliance on transplantations. Regenerative medicine, an interdisciplinary field that applies engineering and life science principles to promote regeneration, can potentially restore diseased and injured tissues and whole organs. Since the inception of the field several decades ago, a number of regenerative medicine therapies, including those designed for wound healing and orthopedics applications, have received Food and Drug Administration (FDA) approval and are now commercially available. These therapies and other regenerative medicine approaches currently being studied in preclinical and clinical settings will be covered in this review. Specifically, developments in fabricating sophisticated grafts and tissue mimics and technologies for integrating grafts with host vasculature will be discussed. Enhancing the intrinsic regenerative capacity of the host by altering its environment, whether with cell injections or immune modulation, will be addressed, as well as methods for exploiting recently developed cell sources. Finally, we propose directions for current and future regenerative medicine therapies.

Keywords: regenerative medicine, tissue engineering, biomaterials, review

Regenerative medicine has the potential to heal or replace tissues and organs damaged by age, disease, or trauma, as well as to normalize congenital defects. Promising preclinical and clinical data to date support the possibility for treating both chronic diseases and acute insults, and for regenerative medicine to abet maladies occurring across a wide array of organ systems and contexts, including dermal wounds, cardiovascular diseases and traumas, treatments for certain types of cancer, and more (13). The current therapy of transplantation of intact organs and tissues to treat organ and tissue failures and loss suffers from limited donor supply and often severe immune complications, but these obstacles may potentially be bypassed through the use of regenerative medicine strategies (4).

The field of regenerative medicine encompasses numerous strategies, including the use of materials and de novo generated cells, as well as various combinations thereof, to take the place of missing tissue, effectively replacing it both structurally and functionally, or to contribute to tissue healing (5). The body's innate healing response may also be leveraged to promote regeneration, although adult humans possess limited regenerative capacity in comparison with lower vertebrates (6). This review will first discuss regenerative medicine therapies that have reached the market. Preclinical and early clinical work to alter the physiological environment of the patient by the introduction of materials, living cells, or growth factors either to replace lost tissue or to enhance the body's innate healing and repair mechanisms will then be reviewed. Strategies for improving the structural sophistication of implantable grafts and effectively using recently developed cell sources will also be discussed. Finally, potential future directions in the field will be proposed. Due to the considerable overlap in how researchers use the terms regenerative medicine and tissue engineering, we group these activities together in this review under the heading of regenerative medicine.

Since tissue engineering and regenerative medicine emerged as an industry about two decades ago, a number of therapies have received Food and Drug Administration (FDA) clearance or approval and are commercially available (). The delivery of therapeutic cells that directly contribute to the structure and function of new tissues is a principle paradigm of regenerative medicine to date (7, 8). The cells used in these therapies are either autologous or allogeneic and are typically differentiated cells that still maintain proliferative capacity. For example, Carticel, the first FDA-approved biologic product in the orthopedic field, uses autologous chondrocytes for the treatment of focal articular cartilage defects. Here, autologous chondrocytes are harvested from articular cartilage, expanded ex vivo, and implanted at the site of injury, resulting in recovery comparable with that observed using microfracture and mosaicplasty techniques (9). Other examples include laViv, which involves the injection of autologous fibroblasts to improve the appearance of nasolabial fold wrinkles; Celution, a medical device that extracts cells from adipose tissue derived from liposuction; Epicel, autologous keratinocytes for severe burn wounds; and the harvest of cord blood to obtain hematopoietic progenitor and stem cells. Autologous cells require harvest of a patient's tissue, typically creating a new wound site, and their use often necessitates a delay before treatment as the cells are culture-expanded. Allogeneic cell sources with low antigenicity [for example, human foreskin fibroblasts used in the fabrication of wound-healing grafts (GINTUIT, Apligraf) (10)] allow off-the-shelf tissues to be mass produced, while also diminishing the risk of an adverse immune reaction.

Regenerative medicine FDA-approved products

Materials are often an important component of current regenerative medicine strategies because the material can mimic the native extracellular matrix (ECM) of tissues and direct cell behavior, contribute to the structure and function of new tissue, and locally present growth factors (11). For example, 3D polymer scaffolds are used to promote expansion of chondrocytes in cartilage repair [e.g., matrix-induced autologous chondrocyte implantation (MACI)] and provide a scaffold for fibroblasts in the treatment of venous ulcers (Dermagraft) (12). Decellularized donor tissues are also used to promote wound healing (Dermapure, a variety of proprietary bone allografts) (13) or as tissue substitutes (CryoLife and Toronto's heart valve substitutes and cardiac patches) (14). A material alone can sometimes provide cues for regeneration and graft or implant integration, as in the case of bioglass-based grafts that permit fusion with bone (15). Incorporation of growth factors that promote healing or regeneration into biomaterials can provide a local and sustained presentation of these factors, and this approach has been exploited to promote wound healing by delivery of platelet derived growth factor (PDGF) (Regranex) and bone formation via delivery of bone morphogenic proteins 2 and 7 (Infuse, Stryker's OP-1) (16). However, complications can arise with these strategies (Infuse, Regranex black box warning) (17, 18), likely due to the poor control over factor release kinetics with the currently used materials.

The efficacies of regenerative medicine products that have been cleared or approved by the FDA to date vary but are generally better or at least comparable with preexisting products (9). They provide benefit in terms of healing and regeneration but are unable to fully resolve injuries or diseases (1921). Introducing new products to the market is made difficult by the large time and monetary investments required to earn FDA approval in this field. For drugs and biologics, the progression from concept to market involves numerous phases of clinical testing, can require more than a dozen years of development and testing, and entails an average cost ranging from $802 million to $2.6 billion per drug (22, 23). In contrast, medical devices, a broad category that includes noncellular products, such as acellular matrices, generally reach the market after only 37 years of development and may undergo an expedited process if they are demonstrated to be similar to preexisting devices (24). As such, acellular products may be preferable from a regulatory and development perspective, compared with cell-based products, due to the less arduous approval process.

A broad range of strategies at both the preclinical and clinical stages of investigation are currently being explored. The subsequent subsections will overview these different strategies, which have been broken up into three broad categories: (i) recapitulating organ and tissue structure via scaffold fabrication, 3D bioprinting, and self assembly; (ii) integrating grafts with the host via vascularization and innervation; and (iii) altering the host environment to induce therapeutic responses, particularly through cell infusion and modulating the immune system. Finally, methods for exploiting recently identified and developed cell sources for regenerative medicine will be mentioned.

Because tissue and organ architecture is deeply connected with function, the ability to recreate structure is typically believed to be essential for successful recapitulation of healthy tissue (25). One strategy to capture organ structure and material composition in engineered tissues is to decellularize organs and to recellularize before transplantation. Decellularization removes immunogenic cells and molecules, while theoretically retaining structure as well as the mechanical properties and material composition of the native extracellular matrix (26, 27). This approach has been executed in conjunction with bioreactors and used in animal models of disease with lungs, kidneys, liver, pancreas, and heart (25, 2831). Decellularized tissues, without the recellularization step, have also reached the market as medical devices, as noted above, and have been used to repair large muscle defects in a human patient (32). A variation on this approach involves the engineering of blood vessels in vitro and their subsequent decellularization before placement in patients requiring kidney dialysis (33). Despite these successes, a number of challenges remain. Mechanical properties of tissues and organs may be affected by the decellularization process, the process may remove various types and amounts of ECM-associated signaling molecules, and the processed tissue may degrade over time after transplantation without commensurate replacement by host cells (34, 35). The detergents and procedures used to strip cells and other immunogenic components from donor organs and techniques to recellularize stripped tissue before implantation are actively being optimized.

Synthetic scaffolds may also be fabricated that possess at least some aspects of the material properties and structure of target tissue (36). Scaffolds have been fabricated from naturally derived materials, such as purified extracellular matrix components or algae-derived alginate, or from synthetic polymers, such as poly(lactide-coglycolide) and poly(ethylene glycol); hydrogels are composed largely of water and are often used to form scaffolds due to their compositional similarity to tissue (37, 38). These polymers can be engineered to be biodegradable, enabling gradual replacement of the scaffold by the cells seeded in the graft as well as by host cells (39). For example, this approach was used to fabricate tissue-engineered vascular grafts (TEVGs), which have entered clinical trials, for treating congenital heart defects in both pediatric and adult patients (40) (). It was found using animal models that the seeded cells in TEVGs did not contribute structurally to the graft once in the host, but rather orchestrated the inflammatory response that aided in host vascular cells populating the graft to form the new blood vessel (41, 42). Biodegradable vascular grafts seeded with cells, cultured so that the cells produced extracellular matrix and subsequently decellularized, are undergoing clinical trials in the context of end-stage renal failure (Humacyte) (33). Scaffolds that encompass a wide spectrum of mechanical properties have been engineered both to provide bulk mechanical support to the forming tissue and to provide instructive cues to adherent cells (11). For example, soft fibrincollagen hydrogels have been explored as lymph node mimics (43) whereas more rapidly degrading alginate hydrogels improved regeneration of critical defects in bone (44). In some cases, the polymer's mechanical properties alone are believed to produce a therapeutic effect. For example, injection of alginate hydrogels to the left ventricle reduced the progression of heart failure in models of dilated cardiomyopathy (45) and is currently undergoing clinical trials (Algisyl). Combining materials with different properties can enhance scaffold performance, as was the case of composite polyglycolide and collagen scaffolds that were seeded with cells and served as bladder replacements for human patients (46). In another example, an electrospun nanofiber mesh combined with peptide-modified alginate hydrogel and loaded with bone morphogenic protein 2 improved bone formation in critically sized defects (47). Medical imaging technologies such as computed tomography (CT) and magnetic resonance imaging (MRI) can be used to create 3D images of replacement tissues, sometimes based on the patient's own body (48, 49) (). These 3D images can then be used as molds to fabricate scaffolds that are tailored specifically for the patient. For example, CT images of a patient were used for fabricating polyurethane and polyethylene-based synthetic trachea, which were then seeded with cells (50). Small building blocks, often consisting of cells embedded in a small volume of hydrogel, can also be assembled into tissue-like structures with defined architectures and cell patterning using a variety of recently developed techniques (51, 52) ().

Regenerative medicine strategies that recapitulate tissue and organ structure. (A) Scanning electron microscopy image of a TEVG cross-section. Reproduced with permission from ref. 41. (B) Engineered bladder consisting of a polyglycolide and collagen composite scaffold, fabricated based on CT image of patient and seeded with cells. Reproduced with permission from ref. 46. (C) CT image of bone regeneration in critically sized defects without (Left) and with (Right) nanofiber mesh and alginate scaffold loaded with growth factor. Reproduced with permission from ref. 47. (D) Small hydrogel building blocks are assembled into tissue-like structures with microrobots. Reproduced from ref. 52, with permission from Nature Communications. (E) Blueprint for 3D bioprinting of a heart valve using microextrusion printing, with different colors representing different cell types. (F) Printed product. Reproduced with permission from ref. 59. (G) Intestinal crypt stem cells seeded with supporting Paneth cells self-assemble into organoids in culture. Reproduced from ref. 67, with permission from Nature.

Although cell placement within scaffolds is generally poor controlled, 3D bioprinting can create structures that combine high resolution control over material and cell placement within engineered constructs (53). Two of the most commonly used bioprinting strategies are inkjet and microextrusion (54). Inkjet bioprinting uses pressure pulses, created by brief electrical heating or acoustic waves, to create droplets of ink that contains cells at the nozzle (55, 56). Microextrusion bioprinting dispenses a continuous stream of ink onto a stage (57). Both are being actively used to fabricate a wide range of tissues. For example, inkjet bioprinting has been used to engineer cartilage by alternating layer-by-layer depositions of electrospun polycaprolactone fibers and chondrocytes suspended in a fibrincollagen matrix. Cells deposited this way were found to produce collagen II and glycosaminoglycans after implantation (58). Microextrusion printing has been used to fabricate aortic valve replacements using cells embedded in an alginate/gelatin hydrogel mixture. Two cell types, smooth muscle cells and interstitial cells, were printed into two separate regions, comprising the valve root and leaflets, respectively (59) (). Microextrusion printing of inks with different gelation temperatures has been used to print complex 3D tubular networks, which were then seeded with endothelial cells to mimic vasculature (60). Several 3D bioprinting machines are commercially available and offer different capabilities and bioprinting strategies (54). Although extremely promising, bioprinting strategies often suffer trade-offs in terms of feature resolution, cell viability, and printing resolution, and developing bioprinting technologies that excel in all three aspects is an important area of research in this field (54).

In some situations, it may be possible to engineer new tissues with scaffold-free approaches. Cell sheet technology relies on the retrieval of a confluent sheet of cells from a temperature-responsive substrate, which allows cellcell adhesion and signaling molecules, as well as ECM molecules deposited by the cells themselves, to remain intact (61, 62). Successive sheets can be layered to produce thicker constructs (63). This approach has been explored in a variety of contexts, including corneal reconstruction (64). Autologous oral mucosal cells have been grown into sheets, harvested, and implanted, resulting in reepithelialization of human corneas (64). Autonomous cellular self-assembly may also be used to create tissues and be used to complement bioprinting. For example, vascular cells aggregated into multicellular spheroids were printed in layer-by-layer fashion, using microextrusion, alongside agarose rods; hollow and branching structures that resembled a vascular network resulted after physical removal of the agarose once the cells formed a continuous structure (65). Given the appropriate cues and initial cell composition, even complex structures may form autonomously (66). For example, intestinal crypt-like structures can be grown from a single crypt base columnar stem cell in 3D culture in conjunction with augmented Wnt signaling (67) (). Understanding the biological processes that drive and direct self-assembly will aid in fully taking advantage of this approach. The ability to induce autonomous self-assembly of the modular components of organs, such as intestinal crypts, kidney nephrons, and lung alveoli, could be especially powerful for the construction of organs with complex structures.

To contribute functionally and structurally to the body, implanted grafts need to be properly integrated with the body. For cell-based implants, integration with host vasculature is of primary importance for graft success () (68). Most cells in the body are located within 100 m from the nearest capillary, the distance within which nutrient exchange and oxygen diffusion from the bloodstream can effectively occur (68). To vascularize engineered tissues, the body's own angiogenic response may be exploited via the presentation of angiogenic growth factors (69). A variety of growth factors have been implicated in angiogenesis, including vascular endothelial growth factor (VEGF), angiopoietin (Ang), platelet-derived growth factor (PDGF), and basic fibroblast growth factor (bFGF) (70, 71). However, application of growth factors may not be effectual without proper delivery modality, due to their short half-life in vivo and the potential toxicity and systemic effects of bolus delivery (45). Sustained release of VEGF, bFGF, Ang, and PDGF leads to robust angiogenic responses and can rescue ischemic limbs from necrosis (45, 72, 73). Providing a sequence of angiogenic factors that first initiate and then promote maturation of newly formed vessels can yield more functional networks (74) (), and mimicking development via delivery of both promoters and inhibitors of angiogenesis from distinct spatial locations can create tightly defined angiogenic zones (75).

Strategies for vascularizing and innervating tissue-engineered graft. (A) Tissue-engineered graft may be vascularized before implantation: for example, by self-assembly of seeded endothelial cells or by host blood vessels in a process mediated by growth factor release. Compared with bolus injection of VEGF and PDGF (B), sustained release of the same growth factors from a polymeric scaffold (C) led to a higher density of vessels and formation of larger and thicker vessels. Reproduced from ref. 74, with permission from Nature Biotechnology. (D) Scaffold vascularized by being implanted in the omentum before implantation at the injury site. Reproduced with permission from ref. 83. (E) Biodegradable microfluidic device surgically connected to vasculature. Reproduced with permission from ref. 85. Compared with blank scaffold (F), scaffolds delivering VEGF (G) increase innervation of injured skeletal muscle. Reproduced from ref. 97, with permission from Molecular Therapy.

Another approach to promote graft vascularization at the target site is to prevascularize the graft or target site before implantation. Endothelial cells and their progenitors can self-organize into vascular networks when transplanted on an appropriate scaffold (7679). Combining endothelial cells with tissue-specific cells on a scaffold before transplantation can yield tissues that are both better vascularized and possess tissue-specific function (80). It is also possible to create a vascular pedicle for an engineered tissue that facilitates subsequent transplantation; this approach has been demonstrated in the context of both bone and cardiac patches by first placing a scaffold around a large host vessel or on richly vascularized tissue, and then moving the engineered tissue to its final anatomic location once it becomes vascularized at the original site (8183) (). This strategy was successfully used to vascularize an entire mandible replacement, which was later engrafted in a human patient (84). Microfluidic and micropatterning techniques are currently being explored to engineer vascular networks that can be anastomosed to the femoral artery (85, 86) (). The site for cell delivery may also be prevascularized to enhance cell survival and function, as in a recent report demonstrating that placement of a catheter device allowed the site to become vascularized due to the host foreign body response to the material; this device significantly improved the efficacy of pancreatic cells subsequently injected into the device (87).

Innervation by the host will also be required for proper function and full integration of many tissues (88, 89), and is particularly important in tissues where motor control, as in skeletal tissue, or sensation, as in the epidermis, provides a key function (90, 91). Innervation of engineered tissues may be induced by growth factors, as has been shown in the induction of nerve growth from mouse embryonic dorsal root ganglia to epithelial tissue in an in vitro model (92). Hydrogels patterned with channels that are subsequently loaded with appropriate extracellular matrices and growth factors can guide nerve growth upon implantation, and this approach has been used to support nerve regeneration after injury (93, 94). Angiogenesis and nerve growth are known to share certain signaling pathways (95), and this connection has been exploited via the controlled delivery of VEGF using biomaterials to promote axon regrowth in regenerating skeletal muscle (96, 97) ().

Administration of cells can induce therapeutic responses by indirect means, such as secretion of growth factors and interaction with host cells, without significant incorporation of the cells into the host or having the transplanted cells form a bulk tissue (98). For example, infusion of human umbilical cord blood cells can aid in stroke recovery due to enhanced angiogenesis (99), which in turn may have induced neuroblast migration to the site of injury. Similarly, transplanted macrophages can promote liver repair by activating hepatic progenitor cells (100). Transplanted cells can also normalize the injured or diseased environment, by altering the ECM, and improve tissue regeneration via this mechanism. For example, some types of epidermolysis bullosa (EB), a rare genetic skin blistering disorder, are associated with a failure of type VII collagen deposition in the basement membrane. Allogeneic injected fibroblasts were found to deposit type VII collagen deposition, thereby temporarily correcting disease morphology (101). A prototypical example of transplanted cells inducing a regenerative effect is the administration of mesenchymal stem cells (MSCs), which are being widely explored both preclinically and clinically to improve cardiac regeneration after infarction, and to treat graft-versus-host disease, multiple sclerosis, and brain trauma (2, 102) (). Positive effects of MSC therapy are observed, despite the MSCs being concentrated with some methods of application in the lungs and poor MSC engraftment in the diseased tissue (103). This finding suggests that a systemic paracrine modality is sufficient to produce a therapeutic response in some situations. In other situations, cellcell contact may be required. For example, MSCs can inhibit T-cell proliferation and dampen inflammation, and this effect is believed to at least partially depend on direct contact of the transplanted MSCs with host immune cells (104). Cells are often infused, typically intravenously, in current clinical trials, but cells administered in this manner often experience rapid clearance, which may explain their limited efficacy (105). Immunocloaking strategies, such as with hydrogel encapsulation of both cell suspensions and small cell clusters and hydrogel cloaking of whole organs, can lead to increased cell residency time and delayed allograft rejection (106, 107) (). Coating infused cells with targeting antibodies and peptides, sometimes in conjunction with lipidation strategies, known as cell painting, has been shown to improve residency time at target tissue site (108). Infused cells can also be modified genetically to express a targeting ligand to control their biodistribution (109).

Illustrations of regenerative medicine therapies that modulate host environment. (A) Injected cells, such as MSCs, can release cytokines and interact with host cells to induce a regenerative response. (B) Polyethylene glycol hydrogel (green) conformally coating pancreatic islets (blue) can support islets after injection. (Scale bar: 200 m.) Reproduced with permission from ref. 107.

Although the goal of regenerative medicine has long been to avoid rejection of the new tissue by the host immune system, it is becoming increasingly clear that the immune system also plays a major role in regulating regeneration, both impairing and contributing to the healing process and engraftment (110, 111). At the extreme end of immune reactions is immune rejection, which is a serious obstacle to the integration of grafts created with allogeneic cells. Immune engineering approaches have shown promise in inducing allograft tolerance: for example, by engineering the responses of immune cells such as dendritic cells and regulatory T cells (112, 113). Changing the properties of implanted scaffolds can also reduce the inflammation that accompanies implantation of a foreign object. For example, decreasing scaffold hydrophobicity and the availability of adhesion ligands can reduce inflammatory responses, and scaffolds with aligned fibrous topography experience less fibrous encapsulation upon implantation (114). Adaptive immune cells may actively inhibit even endogenous regeneration, as shown when depletion of CD8 T cells improved bone fracture healing in a preclinical model (115). Engineering the local immune response may thus allow active promotion of regeneration. For example, the release of cytokines to polarize macrophages to M2 phenotypes, which are considered to be antiinflammatory and proregeneration, was found to increase Schwann cell infiltration and axonal growth in a nerve gap model (116).

Most regenerative medicine strategies rely on an ample cell source, but identifying and obtaining sufficient numbers of therapeutic cells is often a challenge. Stem, progenitor, and differentiated cells derived from both adult and embryonic tissues are widely being explored in regenerative medicine although adult tissue-derived cells are the dominant cell type used clinically to date due to both their ready availability and perceived safety (8). All FDA-approved regenerative medicine therapies to date and the vast majority of strategies explored in the clinic use adult tissue-derived cells. There is great interest in obtaining greater numbers of stem cells from adult tissues and in identifying stem cell populations suitable for therapeutic use in tissues historically thought not to harbor stem cells (117). Basic studies aiming to understand the processes that control stem cell renewal are being leveraged for both purposes, with the prototypical example being studies with hematopoietic stem cells (HSCs) (3). For example, exposure of HSCs in vitro to cytokines that are present in the HSC niche leads to significant HSC expansion, but this increase in number is accompanied by a loss of repopulation potential (118, 119). Coculture of HSCs with cells implicated in the HSC niche and in microenvironments engineered to mimic native bone marrow may improve maintenance of HSC stemness during expansion, enhancing stem cell numbers for transplantation. For example, direct contact of HSCs with MSCs grown in a 3D environment induces greater CD34+ expansion than with MSCs grown on 2D substrate (120). Another example is that culture of skeletal muscle stem cells on substrates with mechanical properties similar to normal muscle leads to greater stem cell expansion (121) and can even rescue impaired proliferative ability in stem cells from aged animals (122).

Embryonic stem (ES) cells and induced pluripotent stem (iPS) cells represent potentially infinite sources of cells for regeneration and are moving toward clinical use (123, 124). ES cells are derived from blastocyst-stage embryos and have been shown to be pluripotent, giving rise to tissues from all three germ layers (125). Several phase I clinical trials using ES cells have been completed, without reports of safety concerns (Geron, Advanced Cell Technology, Viacyte). iPS cells are formed from differentiated somatic cells exposed to a suitable set of transcription factors that induce pluripotency (126). iPS cells are an attractive cell source because they can be generated from a patient's own cells, thus potentially circumventing the ethical issues of ES and rejection of the transplanted cells (127, 128). Although iPS cells are typically created by first dedifferentiating adult cells to an ES-like state, strategies that induce reprogramming without entering a pluripotent stage have attracted attention due to their quicker action and anticipation of a reduced risk for tumor formation (129). Direct reprogramming in vivo by retroviral injection has been reported to result in greater efficiency of conversion, compared with ex vivo manipulation, and allows in vitro culture and transplantation to be bypassed (130). Strategies developed for controlled release of morphogens that direct regeneration could potentially be adapted for controlling delivery of new genetic information to target cells in vivo, to improve direct reprogramming. Cells resulting from both direct reprogramming and iPS cell differentiation methods have been explored for generating cells relevant to a variety of tissues, including cardiomyocytes, vascular and hematopoietic cells, hepatocytes, pancreatic cells, and neural cells (131). Because ES and iPS cells can form tumors, a tight level of control over the fate of each cell is crucial for their safe application. High-throughput screens of iPS cells can determine the optimal dosages of developmental factors to achieve lineage specification and minimize persistence of pluripotent cells (132). High-throughput screens have also been useful for discovering synthetic materials for iPS culture, which would allow culture in defined, xenogen-free conditions (133). In addition, the same principles used to engineer cellular grafts from differentiated cells are being leveraged to create appropriate microenvironments for reprogramming. For example, culture on polyacrylamide gel substrates with elastic moduli similar to the heart was found to enable longer term survival of iPS-derived cardiomyocytes, compared with other moduli (134). In another study, culture of iPS cell-derived cardiac tissue in hydrogels with aligned fibers, and in the presence of electrical stimulation, enhanced expression of genes associated with cardiac maturation (135).

To date, regenerative medicine has led to new, FDA-approved therapies being used to treat a number of pathologies. Considerable research has enabled the fabrication of sophisticated grafts that exploit properties of scaffolding materials and cell manipulation technologies for controlling cell behavior and repairing tissue. These scaffolds can be molded to fit the patient's anatomy and be fabricated with substantial control over spatial positioning of cells. Strategies are being developed to improve graft integration with the host vasculature and nervous system, particularly through controlled release of growth factors and vascular cell seeding, and the body's healing response can be elicited and augmented in a variety of ways, including immune system modulation. New cell sources for transplantation that address the limited cell supply that hampered many past efforts are also being developed.

A number of issues will be important for the advancement of regenerative medicine as a field. First, stem cells, whether isolated from adult tissue or induced, will often require tight control over their behavior to increase their safety profile and efficacy after transplantation. The creation of microenvironments, often modeled on various stem cell niches that provide specific cues, including morphogens and physical properties, or have the capacity to genetically manipulate target cells, will likely be key to promoting optimal regenerative responses from therapeutic cells. Second, the creation of large engineered replacement tissues will require technologies that enable fully vascularized grafts to be anastomosed with host vessels at the time of transplant, allowing for graft survival. Thirdly, creating a proregeneration environment within the patient may dramatically improve outcomes of regenerative medicine strategies in general. An improved understanding of the immune system's role in regeneration may aid this goal, as would technologies that promote a desirable immune response. A better understanding of how age, disease state, and the microbiome of the patient affect regeneration will likely also be important for advancing the field in many situations (136138). Finally, 3D human tissue culture models of disease may allow testing of regenerative medicine approaches in human biology, as contrasted to the animal models currently used in preclinical studies. Increased accuracy of disease models may improve the efficacy of regenerative medicine strategies and enhance the translation to the clinic of promising approaches (139).

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Regenerative medicine: Current therapies and future directions

Dr. Ordon believes he had a bad reaction to fluoroquinolones and explains says he developed Achilles tendinitis due to cipro toxicity, which was very sore and lasted a few months. After he got an MRI, a tear in his Achilles tendon was found, and he attributes these health issues to the fluoroquinolones. To help him heal, he visited internal medicine specialist Dr. Mark Ghalili to get a customized Nad IV therapy protocol that actually helps rebuild the mitochondria within the tendon. Dr. Ghalili says the IV Therapy Dr. Ordon received helped to increase collagen production, reduce pain and increase stamina. Like Dr. Ordon, Dr. Ghalili also had a negative reaction to this type of antibiotic and says he had brain fog, could not walk or care for himself and was confined to a wheelchair for 5 months. He tells us he has treated hundreds of patients for issues related to the use of fluoroquinolones. Dr. Ordon says after enduring this health scare, he will no longer take or prescribe fluoroquinolones. He urges everyone to ask questions about the antibiotics your doctor is prescribing, like if you really need it, what are alternative options?

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Discover the future of medicine

The Master of Science degree program invites you to chart the course for the medicine of the futureregenerative medicine. This is one of the first masters programs in stem cell biology and regenerative medicine in the United States.

Our one-year program offers courses in cutting-edge biomedical science, including developmental biology, human embryology, regenerative medicine, and the translational and therapeutic aspects of stem cell technology. The program also provides practical hands-on laboratory experience with the growth and differentiation of stem cells. Although not required, students are encouraged to engage in laboratory research during the year, with one of the 80+ lab groups that constitute USC Stem Cell. At the completion of the first year, students may informally continue to conduct research in their labs after receiving the MS diploma, or can petition to continue research with a guided and structured second research year culminating in a capstone thesis project.

After completing this program, you will be poised to apply to medical or PhD programs, enter the growing stem cell pharmaceutical domain, or engage in other academic, clinical or business efforts. You will possess a unique understanding of how the bodys own developmental and repair mechanisms can restore damaged cells, tissues and organsproviding new opportunities to treat conditions ranging from blindness to cancer, from organ failure to HIV/AIDS.

To apply, visit gradadm.usc.edu.

Please note that the application portal for Fall 2022 will open October 15th, 2021. The deadline to apply will be April 1st, 2022.

For questions, e-mail us at scrm@usc.edu or call (323) 865 1266.

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MS in Stem Cell Biology and Regenerative Medicine

In Aragonese society, integrative and regenerative medicine has its own name: the clinic Biosalud in Zaragoza, one of the leading centers in this type of medical specialty with more than 30 years of experience behind it. In most medical conferences and symposia, it is inevitable to mention the excellent therapeutic results of this clinic.

The same can be said if we pay attention to Views of Biosalud Zaragoza To publish their patients on the Internet and on social networks, and one of their common characteristics is evaluation, which is usually on the border of excellence.

One of the things that attracts the most attention is his specialization in diagnosing Lyme disease, which is any GPs nightmare.

Lyme disease is a chameleon disorder and its symptoms can be confused with many conditions. In fact, it is one of the most difficult diseases to diagnose and a large percentage of patients are treated for years, without success, for health disorders they do not really have. Likewise, its treatment is not usually simple in all cases and it can last for several months.

Therefore, it is a bacterial infection whose source is usually the bite of a tick carrying the disease.

Contrary to popular belief, it is not a rare disease and its prevalence is increasing in developed societies.

Habits such as hunting, fishing in river areas, going out into the mountains or keeping pets, especially dogs or livestock, increase the likelihood of contracting the disease.

To detect it, it is necessary to use the most advanced diagnostic tools.

in this meaning, Biosalud Day Hospital He has his own test called Lyme CHECK which allows to start a personalized treatment protocol for each patient.

In the medical sector, it is very common to find published opinions that are not satisfied with the care provided. News of medical practice cases that may be categorized as questionable or inappropriate is also very common.

This is not the case with Biosalud Day HospitalIts clinics are rated as excellent by those who have undergone or are still undergoing treatment there.

Take a simple look at the criticisms expressed by patients Biosalud Zaragoza, we can see that positive opinions are clearly the dominant observation. The same thing happens if we take another look at the comments of the Madrid patients.

The common observation is that most of them are people who say that they have, in the past, done multiple medical reviews without finding a satisfactory solution to their health problems.

If you are looking for a second medical opinion or a treatment that truly meets your expectations, in Zaragoza and Madrid you can access the most advanced integrative and regenerative medicine benefits.

With more than 35 years of experience in both fields, in Biosalud Day Hospital They are pioneers in the application of innovative diagnostic systems and integrative therapy for all types of diseases. And not only that, but they also specialize in innovative biological therapies and in detecting overlapping or hidden conditions, such as Lyme disease.

Our advice is to never throw in the towel, assuming you cannot improve your ailments, and you are invited to seek an initial consultation at this centre. If you do, it may not be long before you join the patients publicly expressing their appreciation for medical professionals in clinics. Biosalud.

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Integrative and Regenerative Medicine in its Own Name: Biosalud Clinic in ... - Sunday Vision

Covington, Kentucky--(Newsfile Corp. - October 13, 2021) - CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization announced plans today to offer contract development and manufacturing services. CTI will launch the new initiative, focusing on offerings that will enhance cell and gene therapy capabilities.

The announcement was made during a special company presentation at the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa.

CTI has been on the forefront of life-changing medicine for more than 20 years, working on breakthroughs from some of the earliest developments in immunosuppression to recent discoveries in regenerative medicine. As advancements in medicine trend towards personalized medicine and targeted regenerative therapies, demand for manufacturing capacity has increased, creating a manufacturing shortage.

The facility is estimated to be approximately 40,000 square feet and will initially focus on viral vector manufacturing, ideally to support emerging companies who face challenges in manufacturing priority.

"The decision to build out contract development and manufacturing capabilities was two-fold. First, we are always looking to better serve our biotechnology and biopharmaceutical sponsors and help facilitate the most seamless, efficient clinical trial process possible. Providing manufacturing services will help us better meet the needs of our clients working in the cell and gene therapy space," explains Tim Schroeder, CEO and Chairman of CTI. "Second, and arguably more importantly, we see major challenges that could delay medical advancements and ultimately impact patient lives. If capacity maintains at current levels, manufacturing shortages have the potential to significantly delay future developments in personalized medicine and treatments and cures for disease. Our expertise and resources create a unique position for CTI to make a difference, so we're moving forward to begin to address the challenge."

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The decision to enter into the manufacturing arena follows the company's announcements about expanding laboratory services to support rare disease and cell & gene therapy research across all regions of the world, with a flagship lab set to open in Cincinnati, OH (covering the Americas), and with the acquisition of Dynakin Labs, we will have laboratory services to support Europe and the MEA region. Offering manufacturing, regulatory development and strategy, clinical operations, research site, laboratory, and real-world evidence services, CTI is the only global research service provider with a history of success in regenerative medicine spanning decades and the ability to support cell and gene therapy programs throughout the entire clinical development lifecycle. The company's regenerative medicine experience includes work with more than 1,000 sites, and its current operations can support cell and gene therapy programs in any location across the globe.

"We believe cures for debilitating diseases and prevention of catastrophic illnesses are possible with advances in fields such as regenerative medicine and personalized curative therapies," adds Lynn Fallon, President and Vice-Chair of CTI. "We are privileged to be in a leadership role for these exciting and life-changing projects, and we're looking forward to seeing how our team's and our partners' work will change the medical landscape."

CTI, now in its third decade, is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents. The company was recently named the #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, outperforming dozens of other recognized CROs from around the world. More information about CTI's work in COVID-19 and other complex disease areas can be found at http://www.ctifacts.com.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI's focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI is currently part of more than 30 active COVID-19 projects for treatment and prevention. CTI also offers a fully integrated multi-specialty clinical research site, as well as complete global laboratory services. Now in its third decade, it is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, MEA and Asia-Pacific. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations and for moving medicine forward. For more information visit http://www.ctifacts.com.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/99565

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CTI Announces Contract Development and Manufacturing Initiative During Alliance for Regenerative Medicine Meeting on the Mesa - Yahoo Finance

Question: You are known for your expertise in hormone replacement therapy. What otherareas of medicine do you specialize in?

Answer: I am board certified in primary care, metabolic cardiology, and chiropractic medicine.I am also board certified in physician weightmanagement, anti-aging medicine, aesthetic medicine and physiotherapy. I specialize in anti-aging and regenerative medicine, and I also treat patients who are in need of hormone replacement, cardiac management, mens and womens sexual health, and primary andurgent care. I offer my clients a holistic and personalized approach to healthcare.

Question: People assume that because you dont participate with insurance, yourservices are expensive. Is this true?

Answer: No. Its a misconception as far as pricing. We are able to utilize an individualsinsurance for diagnostic testing and certain medications. The patient pays us directlyfor our services, therefore our time is notlimited with each patient. This allows us to create a dialog and grow a relationship.My goal is to provide health care to everyone regardless of insurance, and our pricesare affordable for everyone.

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