Category Archives: Stem Cell Therapy

The stem cell procedure for the treatment of knee pain is minimally invasive, takes about 3 hours, and patients walk out of the office on their own following treatment. To start, stem cells are harvested from your abdominal or love handle fat using high tech, minimally-invasive liposuction equipment. Stem cells from your bone marrow are also utilized. The bone marrow concentrate is harvested using a specially designed, low-trauma needle which is placed into the posterior iliac crest under live x-ray guidance.

Mild IV sedation, in combination with local anesthetic, is used to provide patient comfort during the procedure. The harvested cells are then prepared for injection using an advanced separation and centrifugation process.

With the use of live x-ray guidance, the cells and growth factors are injected into the affected knee joint under sterile conditions. Dr. Brandts extensive experience with knee injections, along with the aid of the appropriate image guidance, ensures the cells are reaching their targeted area so you have the best chance for improvement.

To complement the high stem cell count achieved with the use of adipose derived stem cells, we often utilize PRP, A2M, and placental derived growth factors during our knee procedures and follow-up treatments.

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Stem Cell Therapy for Knees: Definitive Guide [with ...

Q: What are the types of stem cell therapy?

A: Stem cells are primitive cells that are capable of self-renewal (i.e., to divide to replenish their population); are pluripotent (i.e., able to differentiate into different mature cells); and are able to create, maintain, or repair tissues. There are several general categories of stem cells, including:

Two general stem-cell-based therapeutic strategies have been considered in MS:1

This document addresses AHSCT and MSC transplantation separately.

A: AHSCT is a multi-step procedure, which includes:

Mobilization typically is performed as an outpatient. Conditioning, PBHSC infusion, and initial recovery usually are performed during an approximately 1-month hospitalization in a specialized transplant unit.

A: A sizable number of case series, uncontrolled phase 2 clinical trials, and randomized clinical trials have demonstrated, in aggregate, potent efficacy of AHSCT in patients with active relapsing MS, including marked reduction in relapses, MRI lesion activity, and brain volume loss (after initial acceleration).1-3 In two analyses, the rate of no evidence of disease activity at 2 years was 70-90% in AHSCT case series and trials compared to 15-50% in clinical trials of MS disease modifying therapies (DMTs).4,5 A sizable proportion of patients treated with AHSCT demonstrate improvement in disability, for example, 64% at 4 years in a recent case series.6 Disease control often is durable, lasting up to 15 years or more without the need for ongoing disease modifying therapy (DMT) in many patients.7 Nonetheless, some patients require resumption of standard DMTs at some point after AHSCT, particularly with lower intensity non-myeloablative conditioning regimens.

The potent efficacy is attributed to immunoablative conditioning that depletes pathogenic immune cells; the durability of benefit is attributed more normal regulatory function and T-cell and B-cell repertoires following immune reconstitution.4

A: Early toxicity is common in patients undergoing AHSCT and potentially includes MS relapse during mobilization and conditioning, complications of leukapheresis, side effects of cytotoxic agents comprising the conditioning regimen (e.g., nausea or infertility), complications of myelosupression (e.g., infection or bleeding complications), and engraftment syndrome after re-infusion of PBHSCs (fever, rash, pulmonary edema, liver or renal impairment, and encephalopathy). Patients typically are hospitalized for approximately 1 month when undergoing conditioning and transplantation, and for initial recovery. Previous estimates of overall transplant-related mortality in MS were 2% or more. The current estimate is 0.2-0.3% for AHSCT performed after 2012.4 The improved safety is due to increased experience with the procedure, refinement of the protocol, and better selection of patients with lower risk of complications.

After recovery, adverse effects are rare and include infection (principally related to herpes zoster) and secondary autoimmune disorders. One potential advantage is that after AHSCT patients typically do not need ongoing MS DMT, with the associated cumulative risk of adverse effects.

A: The estimated cost for uncomplicated AHSCT is approximately $150,000. One potential advantage is that after recovery patients typically do not need ongoing MS DMT, with the associated cumulative cost. Nevertheless, most health insurance plans do not cover AHSCT, so obtaining coverage often is difficult.

A: Patients most likely to benefit from AHSCT are young (approximately 55 years or less), with relatively recent disease onset (approximately 10 years or less), still ambulatory, with highly active MS with recent clinical relapses or MRI lesion activity, and continued disease activity despite treatment with approved DMTs especially high-efficacy DMTs. Both the American Society for Blood and Marrow Transplantation 2 and National MS Society3 have published policy statements that AHSCT is a reasonable option in such patients, who are at high risk for disability.

A: Because of the complexity of the AHSCT procedure and the need for appropriate patient selection and follow-up, AHSCT for MS should be performed by centers with expertise and experience in transplant and that are affiliated with centers with experience and expertise in management of MS.1-3We advise patient not to undergo AHSCT in free-standing transplant clinics, especially in the absence of a detailed plan for follow-up and management of medical and neurologic issues post-transplant.

A: Because of the uncertain efficacy and safety of AHSCT compared to approved DMTs for MS, the Mellen Center is participating in the ongoing Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) clinical trial sponsored by the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network (ClinicalTrials.gov Identifier: NCT04047628). This multicenter, randomized, rater-blinded trial compares the efficacy, safety, cost-effectiveness, and immunologic effects of AHSCT versus high-efficacy DMTs in participants with highly active, treatment-refractory, relapsing MS.

Because of unanswered questions regarding the efficacy of AHSCT in MS and substantial associated risk, our priority is to enroll patients for whom AHSCT is being considered into the BEAT-MS trial. We will consider AHSCT outside of the BEAT-MS trial for selected patients for whom AHSCT appears indicated but who are not eligible to participate in the study.

A: Typically, transplant physicians monitor and manage transplant-related adverse effects for the first 6 months following uncomplicated AHSCT (longer if there are complications). After 6 months following uncomplicated AHSCT, transplant-related adverse effects are rare. Patients need to be monitored primarily for symptoms or other findings suggesting infection or secondary autoimmune disorders. Long-term MS disease monitoring is similar to typical MS, with clinical visits and periodic MRIs.

A: Several analyses demonstrated that AHSCT has modest or no efficacy in preventing or reversing progressive disability worsening in the absence of recent relapses or MRI lesion activity. Conversely, the risk of adverse effects and transplant-related mortality are increased in progressive MS due to greater neurologic disability, older age, and increased likelihood of comorbidities. Many of the transplant-related deaths in recent series were patients with progressive MS.4 As a result, AHSCT generally is not advised for patients with non-active progressive MS and/or severe disability.

A: A recent publication reported potent efficacy of non-myeloablative AHSCT in preventing relapses, improving disability, and improving quality of life in 11 patients with aquaporin-4-positive neuromyelitis optica spectrum disorders (NMOSD).8 There now are 3 medications with regulatory approval to treat NMOSD plus several other medications used off-label. The findings from this small uncontrolled case series suggests AHSCT might be an option for patients with NMOSD who do not achieve adequate disease control from the available medication options. Rigorous formal clinical trials are needed to more definitively assess the efficacy and safety of AHSCT in NMOSD. We have not performed AHSCT for NMOSD at Cleveland Clinic.

A: Studies of various stem cell approaches to directly replace myelin-forming cells have been proposed (e.g., transplantation of oligodendrocyte progenitor cells or induced pluripotent stem cells), but none has been completed.1 To date, the most experience is with transplantation of mesenchymal stem cells (MSCs), pluripotent stromal cells present in a perivascular niche in a variety of tissues. In addition to their ability to differentiate into mesodermal lineage derivatives (e.g., bone, cartilage, connective tissue, and adipose tissue), MSCs appear to function to limit inflammatory tissue damage and promote tissue repair, including in the central nervous system, through elaboration of a large number of soluble immunomodulatory and trophic factors. These properties have led to a large number of studies investigating the potential benefit of MSC transplantation to treat a wide variety of inflammatory and tissue injury conditions.1 There also are a large number of commercial stem cell clinics offering MSC transplantation for a wide range of conditions.

A: A sizable number of preliminary trials of MSC transplantation in MS have been reported,1 including one conducted at the Mellen Center.9 These studies had different study populations, cell products, routes of administration, and study protocols, making it difficult to generalize the results. In aggregate, the studies reported good safety and tolerability, and some provided preliminary evidence of benefit. A recent study utilizing cell production procedures intended to augment production of neurotrophic factors by the MSCs and multiple intrathecal administrations, reported more prominent efficacy.10

Despite the sizable number of studies of MSC transplantation, there are a many unanswered technical questions, including the best tissue source (e.g., bone marrow, adipose tissue, or placenta/umbilical cord), whether the cells should be autologous (i.e., from the patient) or allogeneic (i.e., from someone without MS), the optimal cell culture methods to maximize yield and stimulate characteristics that increase therapeutic potency, whether the cells can be cryopreserved (frozen and stored) or need to be harvested directly from culture, dose (i.e., how many MSCs are administered), dosing schedule (i.e., for how long the therapeutic benefit lasts and how often the MSCs need to be administered), and optimal route of administration (i.e., intravenous, intrathecal, or both), among other issues. Because of these unanswered technical questions, MSC transplantation currently is an experimental treatment and should not be performed outside of rigorous formal clinical trials

A: There are a large number of commercial stem cell clinics in the U.S. and other countries offering treatments marketed as stem cells and presumed to be predominantly MSCs, on a fee-for service basis. However, because of the lack of quality control, lack of regulatory oversight, and lack of any validation of their efficacy or safety, we strongly advise patients not to pursue stem cell treatments at commercial stem cell clinics, outside of rigorous formal clinical trials. Many of these operations are potentially fraudulent.

Although MSC transplantation generally has been well-tolerated and safe in formal clinical trials, complications have been reported when administered in commercial stem cell clinics, including among other reports severe loss of vision following intravitreal injection11 and malignant spinal cord neoplasm following intrathecal injection.12

In addition, a number of concerns regarding commercial stem cell clinics have been raised: 13,14

A: Patient who undergo MSC transplantation should be monitored for symptoms or other findings indicating potential complications, including local or systemic infection, ectopic tissue formation, neoplasia, and arachnoiditis (following intrathecal administration). Long-term MS disease monitoring is similar to typical MS, with clinical visits and periodic MRIs.

Last Updated: 10 DEC 2020

Approach last updated: February 14, 2021

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Stem Cell Therapy | Mellon Center Approach | Cleveland Clinic

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Excerpt from:
Stem cells: past, present, and future | Stem Cell Research ...

Stem cell therapy can help heart failure (HF) patients decrease their risk of a non-fatal myocardial infarction (MI) or stroke, according to new research presented at the American Heart Associations Scientific Sessions 2021.

Researchers tracked data from 537 patients with heart failure withreduced ejection fraction (HFrEF).Eighty percent of the patients were men, and the median age was 63 years old.

Patients were split into two groups: 261 patients were injected with 150 million mesenchymal precursor cells [stem cells] provided by healthy donors directly into the heart using a catheter, and 276 patients underwent a fake procedure.

According to the authors, patients were discharged from the hospital the day after the procedure and were followed for an average of 30 months.

Overall, the team associated stem cell use with a 65% decrease in non-fatal MIs and stroke events. Also,patients with high levels of inflammation (CRP levels of at least 2 mg/L) were 79% less likely to have non-fatal MI or stroke after being given stem cells.

Moreover, stem cell treatment lowered cardiac death by 80% in patients with high levels of inflammation and less severe HF.

However, the team added, there was no reduction in hospitalizations for HF among patients who received stem cells.

Cell therapy has the potential to change how we treat HF, lead author Emerson C. Perin, MD, PhD, director of the Center for Clinical Research and medical director of the Texas Heart Institute in Houston, said in a prepared statement. This study addresses the inflammatory aspects of HF, which go mostly untreated, despite significant pharmaceutical and device therapy development. Our findings indicate stem cell therapy may be considered for use in addition to standard guideline therapies.

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Stem cell therapy for heart failure lowers risk of adverse outcomes - Cardiovascular Business

Daniel Wiznia, MD, an orthopaedic surgeon with Yale School of Medicine, is practicing a surgical technique designed to render 10% of hip replacements unnecessary. Regenerative properties from a patients own stem cells are responsible for regrowing bone, restoring blood flow, and being able to avoid further interventional surgery.

Osteonecrosis, also known as avascular necrosis, occurs in more than 20,000 Americans each year. As the condition progresses, bone cells known as osteoblasts become unable to repair themselves and sustain the integrity of the bone, and ultimately die. The bone deterioration leads to a decrease in blood flow to the area, further weakening the entire skeletal structure of the upper leg. If unaddressed, the ball portion of the hips ball and socket joint will cave in on itself and collapse, requiring a total hip replacement.

The fact that patients often receive this diagnosis during their 30s and 40s presents a particular challenge. While the lifespan of hip prosthetics has dramatically increased in recent years, a patient who undergoes a total hip arthroplasty, or total hip replacement, at that age will almost certainly require a revision later in life. This redo of the same surgery at an older age comes with an entirely new set of risks and potential complications, making it that much harder to manage down the road.

The goal in patients with this condition then becomes very clear: prevent the head of the femur (thighbone) from collapsing.

Wiznia, assistant professor of orthopaedics and rehabilitation, and of mechanical engineering and materials science, draws from both of those areas of expertise to use 3D imaging technology as part of an innovative joint-preservation procedure. In recent years, he has worked closely with the Yale School of Engineering & Applied Sciences and the Integrated 3D Surgical Team at the Yale School of Medicine to tailor this treatment to each patient. Imaging has proven to be critical to the successful outcome of this surgical technique.

One of the challenges of orthopaedic surgery in the human body is that surgeons are operating in a three-dimensional space and are often reliant on two-dimensional imagery such as X-rays, Wiznia says. Through computer modeling, we are able to customize those images and create models that are specific to each patient, which, in turn, enhances outcomes and overall post-operative success rates.

Wiznia surgically harvests bone marrow from the patients pelvis. By using a centrifuge inside the operating room, he is able to isolate and concentrate the individuals own stem cells. Material containing the stem cells is then injected into the area of bone that has died.

Research has shown that stem cells possess the characteristics and qualities needed for the body to regrow, repair, and regenerate damaged tissue and bone, and according to Wiznia, this treatment dramatically reduces the risk of the head of the femur from collapsing. Soon after the procedure, many patients with avascular necrosis experience rejuvenated blood supply to the area and the bone is repopulated with new cells. This can additionally alleviate the short-term need for a hip replacement.

The major challenge in this patient population is identifying, diagnosing, and performing surgical intervention in time before the collapse. Because the vascular injury is usually a painless event, says Wiznia, patients are generally unaware of the specific point in time when the injury occurred, which is why cases are rarely discovered in time.

Patients may be encouraged to know that those who have avascular necrosis of the hip generally have it present on both sides, and it can develop on the two sides at different rates. So, even if it is detected too late on one side, there is still a chance to preserve the other.

We usually are able to catch that second asymptomatic side in those situations and conduct the core decompression with stem cell treatment before it collapses, Wiznia says. This novel stem cell therapy has demonstrated improved pain and function, and the stem cells decrease the risk of the femoral head from collapsing. That ultimately translates into fewer young patients requiring hip replacements along with subsequent surgeries in their later years.

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Stem Cell Therapy Reduces Need for Nearly 10% of Hip Replacements - Yale School of Medicine

SEATTLE, Nov. 18, 2021 /PRNewswire/ -- According to Latest Report, The global cell and gene therapy marketis estimated to account for 47,095.2 Mn in terms of value by the end of 2028.

Genetic mutations can lead to a wide range of serious malfunctions at the cellular level, including diseases such as cancer. These treatments use "living drugs" to repair damaged tissues and replace diseased organs, and they have the potential to cure a wide variety of ailments. In addition to regenerating damaged organs, cell and gene therapy can cure cancer, and the treatment process is fast-paced, with significant progress made in recent years. For the cell and gene therapy industry to reach its full potential, early interaction with payers and regulators is crucial. This will facilitate a fast-tracked clinical trial. While embracing new platform technologies is challenging, early collaboration with other industries will ensure a faster path to market for the new therapies. In addition to this, a play-to-win attitude is critical to success in this field. The success of gene and cell therapies will depend on achieving clinical and research goals.

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Market Drivers

1. Increasing incidence of cancer and other target diseases is expected to drive growth of the global cell and gene therapy market during the forecast period

With growing incidence of cancer and target diseases such as measles and tuberculosis, the adoption of gene and cell therapy has increased. According to the World Health Organization (WHO), in 2019, around 1.4 million people died from tuberculosis worldwide with around 10 million people being diagnosed with the same. According to the same source, in 2018, around 9.6 million died due to cancer with over 300,000 new cases of cancer being diagnosed each year among children aged 0-19 years across the globe. Gene therapy uses genes to treat or prevent disease, where it allows doctors to insert a gene into a patient's cells instead of using drugs or surgery. Therefore, it has the potential to completely treat genetic disorders.

2. Growing investments in pharmaceutical R&D activities are expected to propel the global cell andgene therapy market growth over the forecast period

Key pharmaceutical companies in the market are focused on research and development activities pertaining to gene therapy. Currently, gene therapy is being widely researched for various diseases including cancer, cystic fibrosis, hemophilia, AIDS, and diabetes. For instance, in November 2021, Sio Gene Therapies reported positive interim data for gene therapy trial of Phase I/II of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis, a genetic disorder that progressively destroys nerve cells in the brain and spinal cord.

Market Opportunity

1. Increasing demand for cell and gene therapies can present lucrative growth opportunities

The demand for cell and gene therapies is increasing with growing cases of genetic disorders, chronic diseases, etc. According to the Cystic Fibrosis Foundation (CFF), in the U.S., over 1,000 new cases of cystic fibrosis are diagnosed each year. Moreover, According to the WHO, the number of people with diabetes has increased from 108 million in 1980 to 422 million in 2014. According to the same source, in 2016, around 1.6 million deaths were directly caused due to diabetes. Cell and gene therapies have the potential to treat the aforementioned diseases.

2. Growing regulatory approval can provide major business opportunities

Key companies are focused on research and development activities, in order to gain regulatory approval and enhance market presence. For instance, in March 2021, Celgene Corporation, a subsidiary of Bristol Myers Squibb, received the U.S. Food and Drug Administration (FDA) approval for the first cell-based gene therapy Abecma indicated for the treatment of multiple myeloma.

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Market Trends

1. Stem cell therapy

In the recent past, stem cell therapies have gained significant importance across the healthcare sector. Stem cell therapy has the potential to treat tissue damage and have low immunogenicity. Furthermore, it can enhance the growth of new healthy skin tissues, improve collagen production, stimulate hair development after loss, and can be used in the treatment of various diseases including Parkinson's disease, Alzheimer's disease, cancer, spinal cord injury, etc.

2. North America Trends

Among regions, North America is expected to witness significant growth in the global cell and gene therapy market during the forecast period. This is owing to ongoing clinical trials combined with key companies focusing on R&D activities pertaining to cell and gene therapy. Moreover, the presence of key market players such as Thermo Fisher Scientific, Takara Bio Inc., Catalent Inc., and more are expected to boost the regional market growth in the near future.

Competitive Section

Major companies operating in the global cell and gene therapy market are Thermo Fisher Scientific, Merck KGaA, Lonza, Takara Bio Inc., Catalent Inc., F. Hoffmann-La Roche Ltd, Samsung Biologics, Wuxi Advanced Therapies, Boehringer Ingelheim, Novartis AG, and Miltenyi Biotec.

For instance, in July 2021, Minova Therapeutics Inc. entered into a collaboration and license agreement with Astellas Pharma Inc. for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction.

Global cell and gene therapy Market, By Region:

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Cell and Gene Therapy Market to reach US$ 47,095.2 Mn by end of 2028, Says Coherent Market Insights - PRNewswire

J Vasc Surg. 2021 Nov 14:S0741-5214(21)02437-X. doi: 10.1016/j.jvs.2021.10.051. Online ahead of print.

ABSTRACT

BACKGROUND: Atherosclerosis obliterans (ASO) is a chronic occlusive arterial disease and the most common type of peripheral arterial disease. Current treatment options like medication and vascularization have limited effects for no-option patients, and stem cell therapy is considered a viable option although its application and efficacy have not been standardized. The objective of this review was to assess the safety and efficacy of autologous stem cell therapy in patients with ASO.

METHODS: We performed a literature search of published RCTs for ASO patients receiving stem cell therapy without a revascularization option. PubMed, Embase, and the Cochrane Library were searched. This study was conducted by a pair of authors independently and audited by a third author. Data were synthesized with a random-effect model.

RESULTS: 630 patients in 12 RCTs were included. The results showed that cell therapy significantly improved total amputation (RR: 0.64, p = 0.004, 95% CI: [0.47, 0.87]), major amputation (RR: 0.69, p = 0.02, 95% CI: [0.50, 0.94]), ankle-brachial index (ABI) (MD = 0.08, p = 0.004, 95% CI: [0.02, 0.13]), transcutaneous oxygen tension (TcO2) (MD = 11.52, p = 0.004, 95% CI: [3.60, 19.43]) and rest pain score (MD = -0.64, p = 0.007, 95% CI: [-1.10, -0.17]) compared to placebo or standard care. However, current studies showed cell therapy was not superior to placebo or standard care in all-cause death (RR: 0.75, p = 0.34, 95% CI: [0.41, 1.36]) and ulcer size (MD = -8.85, p = 0.39, CI: [-29.05,11.36]).

LIMITATION: The number of trials included was limited. Moreover, most trials were designed for no-option patients and thus the results should be applied with caution to other PAD patients.

CONCLUSION: ASO patients can benefit from autologous cell therapy in limb salvage, limb blood perfusion, and rest pain alleviation.

PMID:34788653 | DOI:10.1016/j.jvs.2021.10.051

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A Meta-Analysis of Randomized Controlled Trials on Therapeutic Efficacy and Safety of Autologous Cell Therapy for Atherosclerosis Obliterans - DocWire...

SINGAPORE, 10 November 2021 Singapore-based viral vector CDMO CellVec announces today that it has been selected as the manufacturer of choice for Australian cell therapy immuno-oncology company Carina Biotech, undertaking the production of GMP-compliant lentivirus constructs for its LGR5 CAR-T. The partnership is slated to advance clinical trials for a treatment designed for patients with advanced colorectal (bowel) cancer.

CellVec is a certified GMP gene therapy contract development and manufacturing organisation that provides an advanced lentiviral vector platform to upscale production of viral vectors and develop novel gene transfer technologies to advance therapies to clinical application. Its strategic offering of bespoke manufacturing services will enable the clinical grade lentivirus to be produced under GMP standards while using Carinas proprietary manufacturing process, progressing the production of LGR5 CAR-T cells for a first in-human clinical trial in H2 2022.

The partnership with Carina Biotech marks a significant milestone for us to facilitate the furtherance of gene therapies. It attests to our capabilities to effectively scale bespoke viral vector manufacturing processes, enabling the advancement of different clinical therapies from bench to bedside that will benefit more patients across the world. We look forward to supporting Carina in the successful development of its LGR5 CAR-T cells, said Dr Ang Peng Tiam, Chairman of CellVec and Medical Director of Parkway Cancer Centre, the largest private oncology service provider in the region.

We are delighted to be working with CellVec because of their outstanding track record and expertise, said Professor Simon Barry, VP of CAR-T Manufacturing Research and Development and the co-inventor of Carinas lead CAR-T cell. Their flexibility and willingness to incorporate Carinas proprietary manufacturing process was an important consideration in the selection of CellVec as our service provider.

Leveraging its advanced CellVec Vector Platform, CellVecs efficacious manufacturing processes will scale the production of high-titre, high yield lentivirus constructs in an accelerated timeline (6 to 8 months) for the project. The LGR5 CAR-T cell targets the LGR5 cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers, resulting in durable tumour suppression and the prevention of relapses commonly seen in patients with colorectal cancer.

We are continuing to see fantastic results with our LGR5 CAR-T cell in pre-clinical testing. Colorectal cancer is Australias second deadliest cancer and its incidence is rising in people under the age of 50 with many of these people being diagnosed with advanced disease and a very poor prognosis, said Dr Deborah Rathjen, CEO of Carina Biotech.

After our recent successful capital raise and welcoming new impact investors to our company, we are on track for a pre-IND submission in Q2 of 2022 and an IND submission to the FDA in the second half of 2022 and the initiation of a Phase I/II clinical trial in patients with advanced colorectal cancer.

Commenting on the potential of the partnership, Dr Gayatri Sharma, Chief Commercial Officer of CellVec said, Carinas work in LGR5 CAR-T therapy aligns strongly with our mission of innovating for patient benefit. Our manufacture of the required lentivirus constructs will accelerate the clinical application and adoption of the therapy, bringing it to more patients around the world and ultimately reduce the incidence and mortality of colorectal cancer. We are pleased to be part of this journey with Carina and are extremely excited for what this will bring to the colorectal cancer community.

CellVec boasts a GMP-certified pharmaceutical quality system (PQS) and facility, awarded by the Health Sciences Authority of Singapore under current PIC/S guidance annexes for medicinal products. These are designed in alignment with US FDA, EU GMP and TGA (Australia) regulations and industry expectations. With a strategic location in Singapore, the regions biotech hub, CellVec is able to facilitate on-time delivery of quality viral vectors across the world, including to the US and the UK.

-ENDS-

About CellVec

CellVec is the first CDMO in Southeast Asia GMP-certified for the production of viral vectors for gene therapy as an active pharmaceutical ingredient. Its manufacturing facility is built to comply with PIC/S, US FDA and EU GMP specifications for viral vectors, upholding quality standards of viral vector production. Specialising in lentiviral vectors, CellVec is a specialist provider of custom viral vectors for pre-clinical and clinical applications. In its commitment towards innovating for patient benefit, CellVec also offers end-to-end project management support to see therapeutics ideas from bench to bedside. For more information, visit http://www.cellvec.com.

About Carina Biotech

Adelaide-based Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. As well as its LGR5-targeted CAR-T cell for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs.

Using its proprietary chemokine receptor platform, Carina aims to improve access to and infiltration of solid cancers by CAR-containing cells resulting in more potent and specific cancer killing and reduced off-target effects in a number of cancers.

Carina also has a fully integrated, proprietary manufacturing process that has both reduced manufacturing time and improved CAR-T cell quality, capable of delivering robust serial-killing CAR-T cells to patients.

About LGR5

LGR5 is acancer stem cell markerthat is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients,LGR5+ expression has been correlated with a particularly poor prognosis.

Cancer stem cells are a small sub-population of cells within a tumour with the ability to self-renew, differentiateinto the many cell types of a tumour, initiatenew tumours, and resistchemotherapy and radiotherapy (leading to relapses).

By targeting cancer stem cells, it is hoped that this therapy will reduce the tumours ability to generate new cancer cells, resulting in durable tumour suppression and preventing the relapses that are very common in patients with colorectal cancer.

Carinas pre-clinical studies of the LGR5-targeted CAR-T cell have shown highly promising results with complete tumour regression and no tumour recurrence. They have also demonstrated impressive tumour access and prolonged CAR-T cell survival.

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New hope for bowel cancer patients as fresh partnership between Carina Biotech and CellVec enables advancement of clinical trials. - Bio-IT World

Industry Growth Forecast Report on Stem Cell Therapy Market size | Segment by Applications (Musculoskeletal Disorder , Wounds & Injuries , Cornea , Cardiovascular Diseases and Others), by Type (Autologous and Allogeneic), Regional Outlook, Market Demand, Latest Trends, Stem Cell Therapy Industry Growth & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyzes current market size and upcoming 5 years growth of this industry.

Stem Cell Therapy Market 2020 Research report contains a qualified and in-depth examination of Stem Cell Therapy Market. At first, the report provides the current Stem Cell Therapy business situation along with a valid assessment of the Stem Cell Therapy business. Stem Cell Therapy report is partitioned based on driving Stem Cell Therapy players, application and regions. The progressing Stem Cell Therapy economic situations are additionally discovered in the report.

The report also includes several valuable information on the Stem Cell Therapy market, derived from various industrial sources. The report studies the competitive environment of the Stem Cell Therapy market is based on company profiles and their efforts on increasing product value and production.

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Top Key Manufacturers in Worldwide Stem Cell Therapy Market Are:

Osiris Therapeutics , Molmed , JCR Pharmaceutical , NuVasive , Anterogen , Chiesi Pharmaceuticals , Medi-post , Pharmicell and Takeda (TiGenix

Porters five forces model in the report provides insights into the competitive rivalry, supplier and buyer positions in the market and opportunities for the new entrants in the global automotive industry over the period of 2020 to 2025. Further, competitive landscape given in the report brings an insight into the investment areas that existing or new market players can consider.

By Structural Form, the Global Stem Cell Therapy Market is segmented into:

Global Stem Cell Therapy market by application:

Musculoskeletal Disorder , Wounds & Injuries , Cornea , Cardiovascular Diseases and Others

The research report provides insight study on:

Why should I buy these reports?

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Global Stem Cell Therapy Market Size, Analytical Overview, Growth Factors, Demand, Trends and Forecast to 2026 - Northwest Diamond Notes

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IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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Stem cell therapy can help combat common symptoms of aging - The Mountaineer