Category Archives: Stem Cell Therapy

The report sheds light on the highly lucrative Global Animal Stem Cell Therapy Market and its diversifying nature. The report provides a detailed analysis of the market segmentation, size, and share; market dynamics such as the growth drivers, restraints, challenges, and opportunities; service providers, investors, stakeholders, and key market players. In addition, the report highlights the threat factors that the market will likely encounter over the forecast period. The report provides detailed profile assessments and multi-scenario revenue projections for the most promising industry participants. The Global Animal Stem Cell Therapy Industry report focuses on the latest trends in the global and regional spaces on all the significant components, including the capacity, cost, price, technology, supplies, production, profit, and competition.

The report also includes a detailed assessment on the key strategies and approaches implemented by the leading industry players and also provides the market share forecasts. The report presents some illustrations and presentations with regards to the market, which includes graphs, tables and pie charts, representing the percentage split of the strategies adopted by the key players in the global market. The product launches are regarded as one of the key strategies adopted by the leading market competitors in the Global Animal Stem Cell Therapy Market so as to present novel and innovative products in different business segments.

Geographically, this report is segmented into several key Regions, with production, consumption, revenue (M USD), market share and growth rate of Animal Stem Cell Therapy in these regions, from 2012 to 2023 (forecast), covering

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Global Animal Stem Cell Therapy market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the top players including

On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate of Animal Stem Cell Therapy for each application, including

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Table of content

1 Report Overview1.1 Definition and Specification1.2 Report Overview1.2.1 Manufacturers Overview1.2.2 Regions Overview1.2.3 Type Overview1.2.4 Application Overview1.3 Industrial Chain1.3.1 Animal Stem Cell Therapy Overall Industrial Chain1.3.2 Upstream1.3.3 Downstream1.4 Industry Situation1.4.1 Industrial Policy1.4.2 Product Preference1.4.3 Economic/Political Environment1.5 SWOT Analysis

2 Product Type Market2.1 World Product Type Market Performance and Trend2.1.1 World Market Performance2.1.2 Different Type of Market Performance2.2 North America Product Type Market Performance and Trend2.2.1 North America Market Performance2.2.2 Different Type of Market Performance2.3 Europe Product Type Market Performance and Trend2.3.1 Europe Market Performance2.3.2 Different Type of Market Performance2.4 Asia-Pacific Product Type Market Performance and Trend2.4.1 Asia-Pacific Market Performance2.4.2 Different Type of Market Performance2.5 South America Product Type Market Performance and Trend2.5.1 South America Market Performance2.5.2 Different Type of Market Performance

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Animal Stem Cell Therapy Market by Manufacturers, Regions, Type and Application, Forecast to 2025 - Market Insights

Geographically, global Animal Stem Cell Therapy market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the top players including

Download FREE Sample of this Report @ https://www.grandresearchstore.com/report-sample/global-animal-stem-cell-therapy-2019-245

On the basis of product, we research the production, revenue, price, market share and growth rate, primarily split into

For the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate of Animal Stem Cell Therapy for each application, including

Production, consumption, revenue, market share and growth rate are the key targets for Animal Stem Cell Therapy from 2013 to 2024 (forecast) in these regions

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Table of content

1 Report Overview1.1 Definition1.2 Manufacturers and Regions Overview1.2.1 Manufacturers Overview1.2.2 Regions Overview1.3 Type Overview

2 Global Animal Stem Cell Therapy Market Assesment by Types2.1 Overall Market Performance2.1.1 Product Type Market Performance (Volume)2.1.2 Product Type Market Performance (Value)2.2 China Animal Stem Cell Therapy Market Performance2.3 USA Animal Stem Cell Therapy Market Performance

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What is our report offers:

Strategic suggestions and proposals for the beginners to understandAssessments of the market share from different countries and regions were conductedTop key market players, market share analysis included.The market observations such as constraints, drivers, threats, opportunities, investment opportunities, challenges, and recommendations are added.The competitive landscaping mappings of the ongoing trends are discussed.Based on the market estimations, the strategic recommendations are made in the business segments

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Animal Stem Cell Therapy Market Research Report 2019 by Manufacturers, Regions, Types and Applications - Market Insights

Last month, we talked about using Mesenchymal Stem Cells (MSC) in Regenerative Medicine to heal degenerative joints and other tissues and organ systems.

When we inject MSCs into damaged areas, we augment the bodys regenerative capacity. MSCs heal damaged tissue by orchestrating the entire healing cascade, providing building blocks for new tissue as well as necessary messenger signaling molecules.

Harvesting cells from C-Section deliveries

Mesenchymal stem cells are harvested from full-term C-section deliveries after the donor has been screened for infectious diseases. The umbilical cord including Whartons Jelly along with the amniotic fluid and sac are harvested and carefully processed.

They are further tested to determine the number of MSCs, structural proteins, cytokines (IL-1, TGF-, TGF-), and growth factors the tissue in question contains. Then they are frozen in liquid nitrogen until needed.

Care is given to inject them in the desired joint or region of the body immediately upon thawing, to preserve viability and increase effectiveness.

Amniotic tissue has been described as fertilizer, while MSCs are new seed, and our tissues are like the soil. The healthier the soil, the better the outcome when new seed and fertilizer are introduced.

There is a bright future for stem cells in many aspects of healing and regeneration. An added benefit is much less recovery time than with surgical procedures.

For information about Nature Cures health programs and retreat, contact the Nature Cure Clinic in Green Valley at 520-399-9212.

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The Bright Future of Stem Cell Therapy: Part 2 - Green Valley News

STOCKHOLM A new trial of autologous mesenchymal stem cells in progressive multiple sclerosis (MS) has shown encouraging results, with significant benefits vs placebo in several measures of disability.

The double-blind placebo-controlled phase 2 study described as "very pioneering" and "provocative" by outside commentators was presented at the recent 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019.

Both intravenous and intrathecal administration of the stem cells showed beneficial clinical effects compared with placebo in terms of Expanded Disability Status Scale (EDSS) changes and several other functional outcomes, but the intrathecal route appeared superior to intravenous administration, reported Dimitrios Karussis, Hadassah University Hospital, Jerusalem, Israel.

Benefits were also noted mainly in the intrathecal group in relapse rates and several other secondary endpoints vs placebo, including timed 25-foot walk test, 9-hole peg test, several measures of cognitive function, and the rate of change of T2 lesion load on magnetic resonance imaging (MRI), as well as newer biomarkers including optimal coherence tomography, retinal nerve fiber layer thickness, and functional MRI motor network.

The study showed both intravenous and intrathecal administration of the cells appeared safe with no serious adverse events observed vs placebo.

"A phase 3 trial is warranted to confirm these findings," Karussis concluded.

Commenting for Medscape Medical News, Robert Fox, MD, Cleveland Clinic, co-chair of the session at which the study was presented, said the study was "provocative" as it showed "quite a robust change in disability trajectory and inflammatory markers despite only including a small number of patients."

"The data suggested a marked impact on these patients with progressive MS," Fox noted. "We've seen other stem cell trials but this is the one with the most provocative results which need to be understood further," he added.

Karussis explained that two small open-label clinical trials of mesenchymal stem cells have previously shown some indications of clinical benefits in MS and amyotrophic lateral sclerosis (ALS) patients in terms of stabilization of disability and some functional improvements.

"This third study is a double-blind, placebo-controlled trial to try and establish safety and the optimal route of administration intrathecal or intravenous injection in progressive MS," he said.

The study included 48 progressive MS patients with activity who had failed on at least one MS therapy and had an EDSS score of 3.0 to 6.5.

Mesenchymal stem cells were aspirated from the bone marrow of each patient, expanded in vivo, and then transplanted back into the patient intrathecally or intravenously at a dose of 1 million stem cells per kg body weight.

Each patient received two injections. For the first injection, 16 patients received stem cells by intrathecal injection, 16 received stem cells by intravenous injection, and 16 received placebo.

After 6 months the patients were crossed over and all patients who first got placebo were given stem cells (half by intrathecal and half by intravenous injection); those who first received stem cells were divided into two subgroups half received a second injection with the same route of administration as the first injection and the other half received placebo.

There was no major difference in baseline demographics in the three groups. Most patients had secondary progressive MS, with about 20% having primary progressive MS. The average EDSS at baseline was about 5.8 with an average progression over the previous year of around +0.7.

Efficacy results showed statistically significant benefits in patients receiving intrathecal stem cell injections vs placebo, with EDSS scores reducing by 0.2 vs an increase of 0.3 in the placebo group. The ambulation score improved by 0.8 points in the intrathecal stem cell group vs an increase of 1.3 with placebo.

The sum of functional scores improved by 3 points in the intrathecal stem cell group vs a worsening by 1 point in the placebo group. The mean number of relapses per patient were 0.06 in the intrathecal stem cell group vs 0.56 in the placebo group, and 94% of the intrathecal stem cell group was relapse free at the end of the study vs 53% of the placebo group.

There were also some smaller but significant improvements in some of the endpoints in the intravenous stem cell group vs placebo but not in the relapse rates, Karussis reported.

For the secondary endpoints patients receiving intrathecal stem cells had significant benefits in the 25-foot walk test, an improvement of 6% to 10% in walking speed vs a deterioration in the placebo group. The 9-hole peg test also showed positive results in the intrathecal stem cell group.

When comparing two treatments vs one treatment, only intrathecally treated patients showed superiority in each of the primary efficacy parameters compared with one treatment.

When asked how much of the effect was thought to be anti-inflammatory, Karussis replied that there appeared to be some dissociation between anti-inflammatory and other effects. "Gadolinium enhancing lesions were much less affected than some other disability parameters, including walking and functional MRI, which may indicate that the main effect was not immunomodulatory," he said.

Fox commented: "It will take a bit of diving into the data to understand how much might have been from an anti-inflammatory effect and how much was truly addressing the progressive facet of the disease."

"One concern was that the second 6 months of treatment patients who then went on placebo seemed to decline quite dramatically," Fox added. "So this begs the question of whether this is just a short-lived benefit and how often will these stem cells treatments need to be given."

Karussis and Fox have disclosed no relevant financial relationships.

35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019: Abstract 157. Presented September 12, 2039.

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'Provocative' Results With Stem Cells in Progressive MS - Medscape

From the NIH Directors Blog by Dr. Francis Collins

Its a race against time when someone suffers a stroke caused by a blockage of a blood vessel supplying the brain. Unless clot-busting treatment is given within a few hours after symptoms appear, vast numbers of the brains neurons die, often leading to paralysis or other disabilities. It would be great to have a way to replace those lost neurons. Thanks to gene therapy, some encouraging strides are now being made.

In a recent study in Molecular Therapy, researchers reported that, in their mouse and rat models of ischemic stroke, gene therapy could actually convert the brains support cells into new, fully functional neurons.1 Even better, after gaining the new neurons, the animals had improved motor and memory skills.

For the team led by Gong Chen, Penn State, University Park, the quest to replace lost neurons in the brain began about a decade ago. While searching for the right approach, Chen noticed other groups had learned to reprogram fibroblasts into stem cells and make replacement neural cells.

As innovative as this work was at the time, it was performed mostly in lab Petri dishes. Chen and his colleagues thought, why not reprogram cells already in the brain?

They turned their attention to the brains billions of supportive glial cells. Unlike neurons, glial cells divide and replicate. They also are known to survive and activate following a brain injury, remaining at the wound and ultimately forming a scar. This same process had also been observed in the brain following many types of injury, including stroke and neurodegenerative conditions such as Alzheimers disease.

To Chens NIH-supported team, it looked like glial cells might be a perfect target for gene therapies to replace lost neurons. As reported about five years ago, the researchers were on the right track.2

The Chen team showed it was possible to reprogram glial cells in the brain into functional neurons. They succeeded using a genetically engineered retrovirus that delivered a single protein called NeuroD1. Its a neural transcription factor that switches genes on and off in neural cells and helps to determine their cell fate. The newly generated neurons were also capable of integrating into brain circuits to repair damaged tissue.

There was one major hitch: the NeuroD1 retroviral vector only reprogrammed actively dividing glial cells. That suggested their strategy likely couldnt generate the large numbers of new cells needed to repair damaged brain tissue following a stroke.

Fast-forward a couple of years, and improved adeno-associated viral vectors (AAV) have emerged as a major alternative to retroviruses for gene therapy applications. This was exactly the breakthrough that the Chen team needed. The AAVs can reprogram glial cells whether they are dividing or not.

In the new study, Chens team, led by post-doc Yu-Chen Chen, put this new gene therapy system to work, and the results are quite remarkable. In a mouse model of ischemic stroke, the researchers showed the treatment could regenerate about a third of the total lost neurons by preferentially targeting reactive, scar-forming glial cells. The conversion of those reactive glial cells into neurons also protected another third of the neurons from injury.

Studies in brain slices showed that the replacement neurons were fully functional and appeared to have made the needed neural connections in the brain. Importantly, their studies also showed that the NeuroD1 gene therapy led to marked improvements in the functional recovery of the mice after a stroke.

In fact, several tests of their ability to make fine movements with their forelimbs showed about a 60% improvement within 20 to 60 days of receiving the NeuroD1 therapy. Together with study collaborator and NIH grantee Gregory Quirk, University of Puerto Rico, San Juan, they went on to show similar improvements in the ability of rats to recover from stroke-related deficits in memory.

While further study is needed, the findings in rodents offer encouraging evidence that treatments to repair the brain after a stroke or other injury may be on the horizon. In the meantime, the best strategy for limiting the number of neurons lost due to stroke is to recognize the signs and get to a well-equipped hospital or call 911 right away if you or a loved one experience them. Those signs include: sudden numbness or weakness of one side of the body; confusion; difficulty speaking, seeing, or walking; and a sudden, severe headache with unknown causes. Getting treatment for this kind of brain attack within fourhours of the onset of symptoms can make all the difference in recovery.

This research was supported in part by NIA grant AG045656.

References:

[1] Chen Y-C, et al. A NeuroD1 AAV-based gene therapy for functional brain repair after ischemic injury through in vivo astrocyte-to-neuron conversion. Molecular Therapy. 2019. Epub Sept. 6.

[2] Guo Z, et al. In vivo direct reprogramming of reactive glial cells into functional neurons after brain injury and in an Alzheimers disease model. Cell Stem Cell. 2014;14(2):188-202. doi: 10.1016/j.stem.2013.12.001.

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Gene therapy shows promise repairing brain tissue damaged by stroke - National Institute on Aging

GOLDEN, CO / ACCESSWIRE / September 26, 2019 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 3rd quarter ended September 24th 2019 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 3rd quarter in Stem Cell Revenues. Vitro Biopharma recorded 3rd quarter revenues of $225,191 vs $141,783 an increase of 59% over the same comparative quarter last year. Current quarter stem cell revenues increased 60% from the prior comparative quarter, consisting of $175,533 for the 3rd quarter ended July 31st, 2019 vs $109,717 for the third quarter ended July 31st, 2018. In the nine months ended July 31st, 2019, revenues were 78% higher than the comparable period in 2018, $629,986 in 2019 versus $354,854 in 2018.

The company's gross profit margins decreased from 76% in the comparative prior year's quarter to 66% in the current quarter. Current COGS is charged with higher cryogenic shipping costs (affecting 5% of COGS) which the company is acting to reduce by stocking inventory at its partners clinic in the Cayman Islands. Subsequent to the quarter its partner in the Cayman Islands established a cryogenic dewar storage facility to support therapies on demand and substantially reducing shipping costs. In addition the current quarter better represents the growth of all the revenue streams represented by AlloRx, InfiniVive, NutraVivo (STEMulize) and Research and Development products. Nine months ended July 31st 2019 margins held up at 71% versus 74% in the prior comparative 9 month period ended July 31st 2018.

Overall operating expenses increased in the quarter by $93,769 to $194,682 from $100,913 in the prior year's comparative quarter. The increase in expenses primarily reflects the increased costs of sales and marketing $27,919, Laboratory certifications (ISO 9001, ISO 13485, CLIA) accounting, regulatory, business development $30,048 and notes interest expenses $20,392. This represents the company's investment in its executive team and outside consultants to support the company's increased business development activities in the Cayman Islands, Bahamas and it's US and international Cosmetic partnership with Infinivive MD, operated by Jack Zamora, MD. For the 9 months ended July 31st 2019 the company grew revenues by 78% while only growing operating expenses by 16%. These investments also provide for further business development opportunities.

During the quarter the company achieved and pursed the following objectives:

Story continues

The company moved forward increasing its manufacturing capacity at its current laboratory facility to support expanded operations and pre-positioning for the expanded manufacturing facilities due to go online in mid-fiscal 2020. During the quarter the company expanded its cell culture incubator capacity, cell analysis equipment and automated cryogenic equipment for expanded and automated production of its AlloRx Stem Cells and its stem cell serum product now branded as InfiniVive MD. The manufacturing equipment added in the 3rd quarter costs were $115,868 and was financed with a 5-year finance facility.

The current expansion has increased our capacity to process 15 Billion AlloRx Stem Cells a month. This represents approximately $ 4 Million of capacity per year. Furthermore, the doubling of manufacturing facility at the beginning of the 2020 year will expand our capacity to approximately 100 Billion AlloRx Stem Cells a month or approximately $1.7 Million of revenue capacity per month. This would give Vitro Biopharma a revenue run rate capacity of $20M a year. This will become our new processing capacity which will be initially 10% utilized and provide for future exponential growth.

Our increased capacity is rigorously controlled by our Quality Management System, now certified to the ISO9001 Quality Standard and the ISO13485 Medical Device Standard as well. This provides cGMP-compliant manufacturing of the highest quality stem cells/medical devices for clinical trial testing to provide further evidence of safety and efficacy for treatment for a wide variety of indications. Highly regulated cGMP biologics manufacturing within an FDA-compliant facility provides numerous opportunities to the Company to drive strong revenue growth. We are presently focused on our partnerships in the Caribbean with DVC Stem in Grand Cayman Island, InfiniVive MD in the US and emerging opportunities in the Commonwealth of the Bahamas. Recent destruction of the Bahamas due to hurricane Dorian have deferred our revenue expectations into the latter part of 2020 versus the beginning of 2020. We are actively pursuing other partnership opportunities as well; including pursuing an FDA-based IND ("Investigational New Drug") with an IRB for musculoskeletal conditions utilizing the business & manufacturing infrastructure that supported the Bahamas IRB approval. We are presently developing opportunities for diagnostic support of clinical trials of TBI and Alzheimer's disease based on our CLIA certified clinical laboratory utilizing multiplexed biomarker profiling.

We have recently reformulated our stem cell activation product, NutraVivo, into a single capsule soft-gel format (STEMulize) that is now undergoing testing prior to commercial release. The company also entered into a memorandum of understanding with New York-based partner Magnus Ventures to develop a Nutraceutical subsidiary for Vitro Biopharma that will focus on nutraceutical therapy of stem cell activation and cellular wellness. The company and its partner are looking to launch the on-line and social media platform for STEMulize in the first half of 2020. The product is currently recommended to our partners' stem cell and cosmetic customers where it is being beta tested for enhancing and supporting cellular wellness in conjunction with the stem cell treatments. The company has scientific data supporting the natural product's capabilities of anti-inflammation, stem cell activation and other cellular effects. The structure of the new company is not finalized but Magnus Ventures is looking to raise between $500,000 to $1,000,000 for the STEMulize subsidiary to support a direct to consumer on-line marketing launch. It is anticipated that Vitro Biopharma will retain over 60% majority control of the new nutraceutical subsidiary.

STEMulize contains natural substances that activate the body's own stem cells to enhance recovery from injury such as TBI, stroke, MS, PD and other autoimmune and neurological diseases. The revised NutraVivo product will be offered as a private label product to InfiniVive clinics and is being implemented as supplemental support to clinical treatments now ongoing in the Cayman Islands. Patients report positive benefits from NutraVivo therapy following stem cell transplants including increased overall energy and improved motor function in MS patients. We are currently testing the new formulation for its commercial release and implementing a name change to STEMulize to reflect its use as a nutraceutical stem cell activator.

The Company's cosmetic stem cell serum private labelled as InfiniVive MD Stem Cell Serum is applied as a topical cosmetic beautification product that is used in conjunction with various skin resurfacing devices. InfiniVive MD continues to expand its base of authorized cosmetic partner clinics and revenues grew 98% in the quarter to approximately $105,000 vs $53,000 in the prior comparative quarter. The cosmetic surgery industry is cyclically slow in the summer months as a result the current quarter cosmetic revenues of $105,000 were lower from the previous second quarter revenues of $130,000. These developments have been in process for the last year and the Joint Development and Supply Agreement dated May 15th 2018 between Vitro Biopharma and Jack Zamora is now producing material results. The agreement requires a minimum level of performance of $1,000,000 annualized by the six-month ended period of June 30th 2020 in order to retain exclusivity in the cosmetic distribution channel.

InfiniVive MD Stem Cell Serum is revolutionizing cosmetic care. The results are delivering reduced down time and an improved beautification experience. The InfiniVive MD product offers many benefits including increased beautification, hydration and improved results compared to alternative cosmetic products. We work with a variety of regulatory consultants to assist us in the appropriate regulatory pathway. The company and its consultants considers InfiniVive MD as a cosmetic beautification product for topical use only.

http://www.jackzamoramd.com http://www.InfiniVivemd.com

Vitro Biopharma's OEM cosmetic topical serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product used in conjunction with various skin resurfacing devices. To date the company's product is being offered in 10 cosmetic clinics.

Our clinical trial entitled "Vitro Biopharma Allogeneic MSC Therapy of Musculoskeletal Conditions" was approved by the National Stem Cell Ethics Committee of the Bahama's on February 26, 2019. Subsequent to its 3rd quarter, the executive team of Vitro Biopharma visited Dr. Conville Brown and toured his facilities at the Medical Pavilion of the Bahamas. Subsequent to our trip and plans, hurricane Dorian wiped out the Islands of Abaca and Grand Bahamas but significantly spared Nassau where our partner clinic is located. However the government and hospital facilities are being taxed by devastation to property and the people. The company expects these developments to set back its revenue plans into the later half of 2020.

About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of ''FDA rigor in a Non-FDA Jurisdiction'' TMPB employs 20 medical specialists in various fields. See http://www.tmp-bahamas.com for additional information.

While our plans in the Bahamas have been set back there is currently no revenue contribution loss, only a delay in expanding our revenue diversification.

During the quarter Vitro Biopharma continued to expand its clinical trial business in the Cayman Islands with its partner http://www.DVCStem.com under the joint IRB covering inflammatory conditions. Treatments to date have covered MS (Multiple Sclerosis), OA(Osteoarthritis), PD (Parkinson's disease) and other inflammatory conditions. DVC Stem specializes in clinical stem cell regenerative medicine utilizing Vitro Biopharma's AlloRx Stem Cells under approval of the Ministry of Health of the Cayman Islands. Subsequent to the quarter, our executive team visited DVC Stem to train personal in stem cell deployment & cryogenics based on their new onsite cryogenic storage facility.

Our overall objectives are to support high quality offshore medical stem cell tourism with clinical trial partners worldwide.

The Company has several patent applications (11) pending in the US and foreign jurisdictions. These patents cover our AlloRx Stem Cell line and various aspects of our NutraVivo stem cell activation products & processes as well as specific diagnostic tests of stem cell activity and therapeutic effectiveness. During the quarter, the Company has responded to office actions and continues to vigorously prosecute & expand its patent filings.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased to report the results of operations through our 3rd fiscal quarter in 2019. We experienced strong revenue growth over the comparative prior year quarter. Our 3rd quarter is typically a cyclical low quarter as the Research products are not in demand during the summer period as well as it is a cyclically low quarter for the cosmetic revenue stream. The company expects with continued increases from all revenue categories that it will be cash flow positive in mid. 2020 and report its first net quarterly profit in the later 2020 timeframe.

We have added several regulatory certifications and outside oversight of our biomanufacturing operations. We are now ISO9001, ISO13485 and CLIA certified and cGMP compliant. Our regulatory certifications allow us to gain offshore IRB approvals, e.g., in the Commonwealth of the Bahamas and other countries since the ISO Standards are internationally recognized. Certification to these rigorous standards are often required to perform manufacturing operations supporting IRB-approved clinical trials, especially in foreign jurisdictions.

Our stem cell products are distinctly superior to stem cell transplants in the USA. The latter usually involve use of impure products lacking validation as stem cells and containing insufficient numbers of stem cells to achieve therapeutic benefits. These are produced without regulatory oversight and have been known to cause serious adverse effects. Hence the use of highly purified and well characterized stem cells (AlloRx Stem Cells) is needed to provide safety and efficacy in regenerative medicine therapies. Results from our clinical studies show safe administration of AlloRx Stem Cells and evidence of efficacy in OA ("Osteoarthritis"), MS ("Multiple Sclerosis") and PD ("Parkinson's Disease")

Our Research and Development team is developing a novel product for clinical applications, called AlloEx Exosomes. Exosomes are secreted from stem cells and may mediate therapeutic benefits without the use of stem cells. The mechanism of stem cell effects on the body is complex, but exosomes offer an important line extension to AlloRx that represents further revenue diversification opportunities for Vitro Biopharma.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10+ years experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapies. We continue to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide."

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro Biopharma(303) 999-2130 Ext. 1E-mail: jim@vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.www.vitrobiopharma.com

Vitro Diagnostics, Inc.3rd Quarter ended July 31st;Income Statement

2019

2018

Stem Cell Therapies and Treatments

175,533

109,717

Stem Cell Products

49,658

32,066

Other Services

-

-

Total Revenues

225,191

141,783

-

COGS

75,623

34

%

33,527

24

%

Gross Profit

149,569

66

%

108,256

76

%

SGA Expenses

77,387

44,327

Office Expenses

12,524

11,758

Consulting,Accounting,Legal and Banking Fees

66,035

6,419

Laboratory R&D & Quality Control

38,736

38,409

Total Operating Expenses

194,682

100,913

Net Operating Profit (Loss)

(45,113)

7,343

Non Cash Depreciation and Amortization

(13,627)

(11,767)

Non Cash Stock for Services

Non Cash Interest on Secured Notes Payable

(23,614)

(2,808)

Non Cash Interest on Shareholder Debt

(9,193)

(10,106)

Net Income (Loss)

(91,547)

(17,338)

Vitro Diagnositics Inc.3rd Quarter Ended July 31st;Balance Sheet

2019

2018

ASSETS

Cash

97,725

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Vitro Biopharma 3rd Quarter ended July 31st 2019 Financial Results of Operations - Yahoo Finance

Press release

Gosselies, Belgium, 27 September 2019, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, today announces that Dr.Olivier Godeaux, Chief Medical Officer of Bone Therapeutics, will give a keynote presentation at the 2nd World Congress on Rheumatology & Orthopedics (WCRO) in Paris, France, today at 10:45am CEST.

WCRO serves as an international platform to bring prominent speakers, renowned scientists, professors, deans, surgeons, physicians, medical and industrial professionals, and business delegates together to exchange new insights and to share recent progress in the field of rheumatology and orthopaedics. The event is supported by 20 orthopaedic societies in Europe, America and Asia and is expected to receive participants and experts from over 40 countries across the globe.

The oral presentation will discuss the results from the Phase II/III study with JTA-004, Bone Therapeutics novel enriched protein solution, currently in development for the treatment of osteoarthritis of the knee.

Presentation Details:

Title: Safety and efficacy of intra-articular injection of JTA-004, a novel supplemented protein solution, in symptomatic knee osteoarthritis: a randomized, double-blind controlled phase II/III studyAuthors: Marie Bettonville1, Anne-Sophie Delmarcelle1, Marc Lon2, Bogdan Ster3, Jean-Franois Kaux4, Thierry Appelboom5, Jolle Margaux6, Didier Urbin-Choffray7, Emilie Theunissen8, Tatiana Besse-Hammer9, Philippe De Greift10, Jiangang Qu11, Yves Fortems12, Sverine Verlinden13, and Olivier Godeaux1Date: Friday, 27 September 2019Time: 10:45 11:15am CESTLocation: Main Hall, Holiday Inn Paris - Porte de Clichy, France

1Bone Therapeutics S.A., Belgium; 2CHU Ambroise Par, Belgium; 3CHU Saint-Pierre, Belgium; 4University and University Hospital of Lige, Belgium; 5Hpitaux Iris Sud Molire Longchamp, Belgium; 6CUB Erasme, Belgium; 7CHR Citadelle, Belgium; 8Clinique Saint-Pierre Ottignies, Belgium; 9CHU Brugmann, Belgium; 10CHR de Namur, Belgium; 11Hpitaux Iris Sud Etterbeek-Ixelles, Belgium; 12AZ Sint Jozef, Belgium; 13CHR Haute Senne, Belgium.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy and an innovative biological product in later-stage clinical development across a number of disease areas, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its allogeneic cell therapy platform (ALLOB) which uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, cutting-edge manufacturing process.

The Companys ALLOB product pipeline includes a cell therapy product candidate that is expected to enter PhaseII/III clinical development for the treatment of delayed-union fractures and a PhaseII asset in patients undergoing a spinal fusion procedure. In addition, the Company is also developing an off-the-shelf protein solution, JTA-004, which is expected to enter PhaseIII development for the treatment of pain in knee osteoarthritis.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAThomas Lienard, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

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Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics to present data from its Phase II/III trial with JTA-004 at the 2nd World Congress on Rheumatology & Orthopedics - Yahoo Finance

At 34, Noveel Pandya is an aspiring billionaire who has made it big right here in the UAE. Image Credit: Atiq-ur-Rehman / Gulf News

Dubai: At 34, Noveel Pandya is a billionaire who has made it big right here in the UAE. While it would bealright to say he is more blessed than others his father, Narendra Pandya, ran an established business in the UAE before Noveel started Noveel is attempting to makea mark withhis own venture,Bioscience Clinic Middle East.

Senior Pandya runs a successful business House of Chemicals (HOC) - as a distributor of specialty and commodity chemicals for key suppliers especially in businesses such as oil drilling, refineries, gas plants, lubricant plants, water treatment for desalination plants and sewage treatment.

Pandya,Noveels father,also started another company BDH with an expertise in supply, installation, commissioning and maintenance of all laboratory equipment and furniture.

We are pretty much the turnkey laboratory projects expert, said Noveel, in an interview with Gulf News at his house in Emirates Hills.

But Noveels babyBioscience Clinic Middle East a center offering regenerative medicine and personalised autologous cell therapies brings him much pride and cheer. Premium services of the company include cryopreservation and expansion of cells used for anti-aging treatments, aesthetic and plastic surgery, wound care and for dermatological imperfections.

Starting from the bottom up

With a family-run business, it was perhaps a given for Noveel to become a businessman himself and run his fathers mantle.

But this was not achievedbefore he had to work his way up to the top.

In fact I started from bottom low. There was no way my father was going to have me take over peoples jobs in the company who had put in years of hard work. So there was a huge process of learning one that taught me humility and gratitude for the people who are part of our team, he said.

Noveels father came to work in the UAE in the early 70s. He said, From the stories I hear from him - there were many challenges and struggles he faced. In fact, lots of people who came with him to work in the UAE returned home.

It wasn't handed on a platter

Before jumping to the conclusion that he had it all easy,Noveel had to prove his capabilities just like any employee of the firm and had to work his way up the ladder.

There was no way my father was going to let me work above all those people who had put in so many years of service. From 2007 until 2011 it was all about learning and observation.

Take this: From the time Noveel completed his MBA in London in 2011 to join the family, he has helped the family business grow by a 100 per cent year on year.

Noveel said, BDH for example was making Dh35 million in 2007, but today, it is making over Dh140 million.

As for his own venture, there is massive potential for Bioscience Clinic Middle East as the stem cell venture business for the MENA region is tipped to be around two million dollars.

According to a report published in April 2019, the global stem cell market size is expected to reach $15.63 billion by 2025.

Today, we have little competition in the MENA region, so as you can see, there is a massive potential to grow.

Reverse-aging with stem cell therapy

Noveel said typically a client would reach out to a clinic to undergo a full scan and evaluation. A consultation with specialised doctors follows. Once the evaluation is done and the patient passes the test to become a candidate for the stem cell venture project, the doctor executes a plan to extract fat from the persons body.

This fat stores stem cells and we extract it from the fat. We have advanced technology in place to do the job for this. The stem cells derived are stored in vials and frozen, he explained.

The stem cells are multiplied to a couple of hundred million or sometimes a billion in order to produce the required volume.

Noveel said: When the stem cells are frozen they stop the ageing process of the cells. This means it effectively helps reverse-age a person. If someone at the age of 30 comes to us and asks us to freeze their cells. We do it. The person can always come back ten or 15 years later to rejuvenate their skin, hair or any part of their body. Just imagine at 45 or 50, this person wants to rejuvenate their skin. What we will do is inject their cells which were frozen when they were 30. When these cells are injected, they will leave the person with a skin looking as young as 30.

Stem cell therapy is said to be the most natural way to rejuvenate your skin, body and cells. The concept is called autologous which means it is your own cells which go into your body - not that of siblings or parents. Basically it is your own cells which are injected to the body and it is the most natural way to rejuvenate your body and skin.

How long does it take for the body to rejuvenate?

It depends on the body type, the persons lifestyle, food habits and more. This can take from a couple of weeks to a whole month. Remember, this is not an overnight fix. In fact treatments that come with overnight fixes can be very dangerous. Anything that has a drastic effect on your body is not good at all, explained Noveel.

We have seen fine lines or wrinkles disappearing in seven to 15 days after the cells were injected. The effect of the cell injected can last up to a year or over a year. But it all depends on the body type. Remember, your body can never reject your own cells it always accepts its cells.

Our clients are people from the age 18 and above. People who use alternative treatments come to us. I had a 63-year-old man come in from India saying they wanted their stem cells extracted.

Screening process

When a person comes there is a screening process that goes in. Upon successfully passing the screening process, other factors expel candidates like those who are typically heavy smokers or people with certain existing medical conditions. If a client has a virus present in the body, that would drastically effect the quality of cells. If the quality of cells we get right in the beginning is poor the effect will not be desirable for them. Similarly, if the person is diagnosed with some STDs, certain terminal illness, we do not recommend them to store their cells.

Package cost

An initial package offered by Bioscience Clinic Middle East is close to Dh15,000 which includes a consultation, cell extraction, one year storage of stem cells and application. The application can be used anytime. One is not forced to use it immediately.

We are the only business in the region offering such services, Noveel claimed.

Business investment

Noveel said he invested 5 million euros in Bioscience Clinic Middle East.

This money went in for the facilitation of the lab, the treatment, and consultation, hiring skilled professionals and setting up class clean rooms for storing stem cells. Remember we are talking about a niche industry and a very niche product. The investment is for this.

Challenges as a millennial

There is a definite need to make an effort to be heard. Sometimes we are not taken seriously and that is the only challenge I see for myself today. But never give up. Keep dreaming and have the zest to grow. Patience is a virtue that we millennials need to build. Success does not come overnight. For example, my break-even did not happen for long. But I kept at my dreams and went after my goals. This is critical, Noveel said

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Meet Noveel Pandya: Indian multi-millionaire whose stem cell venture project is the talk of town - Gulf News

TheU.S. Food and Drug Administration (FDA) has granted Magenta Therapeuticscell therapy MGTA-456 the Regenerative Medicine Advanced Therapy (RMAT) designation for treating inherited metabolic disorders, including cerebral adrenoleukodystrophy.

The RMAT designation is a program established to help expedite the development and approval of promising therapies. It isgiven to products that have preliminary clinical evidence of being able to treat, modify, or cure a serious or fatal disease, and potentially address unmet medical needs for that disease.

This RMAT designation was based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative, life-saving potential of MGTA-456 for children suffering from inherited metabolic disorders, John Davis, MD, chief medical officer at Magenta Therapeutics, said in press release.

MGTA-456 is a stem cell-based therapy specifically,allogenic hematopoietic stem cell therapy (HSCT) designed to help stop the progression of inherited metabolic disorders. This is possible through the delivery of a high-dose of stem cells to help regenerate the patients immune system. The procedure requires patients to receive a transplant of healthy blood-forming cells, orhematopoietic stem cells (HSCs), from a genetically identical donor (allogenic), to replace their own diseased cells.

MGTA-456 is being developed as a treatment for multiple diseases.

The therapy is currently being evaluated by Magenta in a Phase 2 clinical trial (NCT03406962) in patients with various genetic metabolic disorders, including cerebral adrenoleukodystrophy (cALD), Hurler syndrome, metachromatic leukodystrophy, or globoid cell leukodystrophy. All participants are older than 6 months.

This Phase 2 clinical trial is being conducted at four U.S. medical centers: Cincinnati Childrens Hospital, Duke University, Emory University, and the University of Minnesota.

Previous results from the first five patients two of them with cALD who were followed for six months, showed a rapid and consistent benefit withMGTA-456 treatment that was not seen with other investigational therapies.

Patients with cALD, in particular, were found to have resolution of brain inflammation on magnetic resonance imaging (MRI) scans, as early as 28 days after the treatment.Additionally, patients had stable neurological function scores at six months post-treatment, suggesting that the progression of the disease was halted.The Loes score, which quantifies the severity of brain abnormalities and atrophy, also was stable at six months.

All five patients analyzed achieved the primary goal of neutrophil engraftment, in which levels of neutrophils (a type of immune cell) have reached an absolute count of 500 or more neutrophils per cubic millimeter of blood for three consecutive days. Of note, a robust neutrophil engraftment means that the transplant of the stem cells was succeeded.

Following the success of this trial, Magenta expects to present further data before the end of 2019.

We look forward to collaborating closely with the FDA as we seek to rapidly advance MGTA-456 through the ongoing Phase 2 study, and into potential pivotal studies in 2020, Davis said.

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MGTA-456 Earns Regenerative Medicine Advanced Therapy Designation - Adrenoleukodystrophy News

Patients who are beyond treatment under the standards of conventional medicine often seek help from alternative medical treatments; however, these methods pose not only medical risks for patients, but also legal risks for doctors.

Facts

A surgeon with qualifications in vascular, heart and thorax surgery treated seriously ill patients using an innovative method. The patients suffered from morbus Parkinson, multiple sclerosis, various forms of myatrophy and paralysis, traumatic spinal cord injuries, macular degenerations or psychiatric impairments such as autism. All of the patients were beyond treatment under the standards of conventional medicine. The surgeon treated them with stem cell therapy.

First-instance and appeal decisions

In April 2014 the Viennese Administrative Authority fined the surgeon under Section 49(1) of the Act on the Medical Profession for failing to observe patient welfare namely, for not evaluating the side effects and counterindications of using stem cell therapy to treat the abovementioned conditions.

In July 2015 the Viennese Administrative Tribunal(1) partly confirmed this decision. The tribunal ruled that potential health risks cannot be withheld from patients.

Supreme Administrative Court decision

On appeal, the Supreme Administrative Court(2) overruled the Viennese Administrative Tribunal's decision. The court held that the administrative tribunal had accused the surgeon of regularly using autologous stem cell therapy as a new treatment, even though clinical studies had yet to determine its benefits and risks.

According to the court, stem cells fall within the definition of medicinal products under Section 1 of the Medicinal Products Act.(3) The court could therefore revert to the doctrine and precedents on the off-label use of medicinal products. In its view, the tribunal had not shown that the treatment was clearly prohibited. Further, without a prohibition on the off-label use of medicinal products with marketing authorisation, such a prohibition cannot be based on the Medicinal Products Act. Therefore, an infringement of "compliance with existing rules according to sec 49 (1) Act on the Medical Profession" was not obvious.

The use of medicinal products or treatments that have not been clinically evaluated in terms of benefit-risk ratio for certain (new) indications is referred to as 'compassionate use'. The Declaration of Helsinki on ethical principles for medical research involving human subjects states as follows:

Unproven interventions in clinical practice

37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

According to legal literature, compassionate use is a deviation from medical standards in special treatment situations, either because the standard is unhelpful or no standard for the special treatment is available. Unlike clinical studies, it refers to individual cases and not to a clinical sample.

Under Section 49(1) of the Medical Profession Act physicians must observe the rules of medical science; however, these rules are only guidelines with respect to patient welfare insofar as it is possible to go beyond conventional medicine. Therefore, Section 49(1) does not prohibit compassionate use for patients who are beyond therapy under conventional medicine if they are comprehensively informed and the compassionate use makes objective sense.(4)

There is no legal definition of 'compassionate use' and no Supreme Court precedents in this regard. On 13 February 1956 the German Federal Court ruled(5) that a method of treatment is a clinical study and not a compassionate use if the method is applied not primarily in the interests of treating a patient, but in the interest of scientific research. A new method of treatment may be applied if the responsible medical evaluation and comparison of the expected benefits and risks of the new method with the standard treatment under consideration justify its application.(6)

New methods may be used only on patients who are fully informed that said methods imply unknown risks. Further, patients must be able to evaluate and consent to (or not) said risks.(7)

In the case at hand, all of the surgeon's patients were beyond treatment such that, according to the medical standard, no successful cure could be expected at the time of the treatment.

The Viennese Administrative Tribunal failed to establish that the applied treatment had posed a danger to the patients; rather, it stated only that health risks cannot be excluded without clinical studies. The tribunal reproached the applicant for integrating the method of treatment into regular clinical operations. Compassionate use that is legitimate in individual cases becomes illegitimate if it is adopted in regular clinical operations, as it becomes a regular treatment with an unverified method. This further implies that the person administering the treatment has applied it in multiple cases. It is unclear whether the application of a new therapy on a larger number of patients excludes the qualification of the treatment as compassionate use.

Insofar as the Viennese Administrative Tribunal questioned the surgeon's claim to have evaluated the risks of stem cell therapy in each case, the tribunal lacked evidence to evaluate the types of risk that would prohibit compassionate use. Further, the tribunal failed to establish the circumstances and specific patient information that would prohibit compassionate use. Therefore, the Supreme Administrative Court set aside the Viennese Administrative Tribunal's decision.

Comment

The Supreme Administrative Court's decision appears to favour a liberal approach to new therapies and compassionate use and enhances the possibilities for developing new therapies and alternative medicines in future. However, patient welfare remains paramount for qualifying a new method as compassionate use.

Endnotes

(1) VGW-001/047/26739/2014-28.

(2) 24 April 2019, RA 2015/11/0113.

(3) Kopecky, Stammzellenforschung in sterreich, 2008, 269.

(4) Resch and Wallner, Handbuch Medizinrecht (second edition), 2015, 222.

(5) III ZR 175/54.

(6) German Federal Court of Justice, 13 June 2006, VI ZR 323/04.

(7) German Federal Court of Justice, 13 June 2006, VI ZR 323/04 and Federal Court of Justice, 27 March 2007, VI ZR 55/05.

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide.Register for a free subscription.

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Alternative medical treatments and compassionate use - Lexology