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Stem cells: Therapy, controversy, and research

The idea of a miracle cure and bodies healing themselves holds a particular fascination. Stem cell research brings regenerative medicine a step closer, but many of the ideas and concepts remain controversial. So what are stem cells, and why are they so important?

Stem cells are a type of cell that can develop into many other types of cell. Stem cells can also renew themselves by dividing, even after they have been inactive for a long time.

The human body requires many different types of cell to function, but it does not produce each cell type fully formed and ready to use. Instead, it produces stem cells that have a wide range of possible functions. However, stem cells need to become a specific cell type to be useful.

When a stem cell divides, the new cells may either become another stem cell or a specific cell, such as a blood cell, a brain cell, or a muscle cell.

Scientists call a stem cell an undifferentiated cell because it can become any cell. In contrast, a blood cell, for example, is a differentiated cell, because it is already a specific kind of cell.

In some tissues, stem cells play an essential role in regeneration, as they can divide easily to replace dead cells.

Scientists believe that knowing how stem cells work may lead to possible treatments for conditions, such as diabetes and heart disease.

For instance, if someones heart contains damaged tissue, doctors might be able to stimulate healthy tissue to grow by transplanting laboratory-grown stem cells into the persons heart. This could cause the heart tissue to renew itself.

Researchers on a small-scale study published in the Journal of Cardiovascular Translational Research tested this method.

The results showed a 40 percent reduction of the size of scarred heart tissue caused by heart attacks when doctors transplanted stem cells to the damaged area.

Doctors have always considered this kind of scarring permanent and untreatable.

However, this small study involved only 11 participants. This makes it difficult to tell whether the improvement in heart function resulted from the transplantation of stem cells or whether it was due to something else.

For example, all of the transplants took place while the individuals were undergoing heart bypass surgery, so it is possible that the improvement in heart function was due to the bypass rather than the stem cell treatment.

To investigate further, the researchers plan to do another study. This study will include a control group of people with heart failure who undergo bypass surgery but who do not receive the stem cell treatment.

Another investigation, published in Nature Communications in 2016, has suggested that stem cell therapies could be the basis of personalized diabetes treatment.

In mice and laboratory-grown cultures, researchers successfully produced insulin-secreting cells from stem cells derived from the skin of people with type 1 diabetes.

Jeffrey R. Millman, assistant professor of medicine and biomedical engineering at Washington University School of Medicine and first author, says:

In theory, if we could replace the damaged cells in these individuals with new pancreatic beta cells whose primary function is to store and release insulin to control blood glucose patients with type 1 diabetes wouldnt need insulin shots anymore.

Jeffrey R. Millman

Millman hopes that these stem cell-derived beta cells could be ready for research in humans within 3 to 5 years.

What were envisioning is an outpatient procedure in which some sort of device filled with the cells would be placed just beneath the skin, he said.

Stem cells could have vast potential in developing new therapies.

One way that scientists use stem cells at the moment is in developing and testing new drugs.

The type of stem cells that scientists commonly use for this purpose are called induced pluripotent stem cells.

These are cells that have already undergone differentiation, but which scientists have genetically reprogrammed using viruses, so they can divide and become any cell. In this way, they act like undifferentiated stem cells.

Scientists can grow differentiated cells from these pluripotent stem cells to resemble, for instance, cancer cells. Creating these cells means that scientists can use them to test anti-cancer drugs.

Researchers are already making a wide variety of cancer cells using this method. However, because they cannot yet create cells that mimic cancer cells in a controlled way, it is not always possible to replicate the results precisely.

In recent years, clinics have opened that provide stem cell treatments.

A 2016 study published in Cell Stem Cell counted 570 of these clinics in the United States alone. They offer stem cell-based therapies for disorders ranging from sports injuries to cancer.

However, stem cell therapies are still mostly theoretical rather than evidence-based.

Very few stem cell treatments have even reached the earliest phase of a clinical trial. Scientists are carrying out most of the current research in mice or a petri dish.

Despite this, the U.S. Food and Drug Administration (FDA) allow clinics to inject people with their own stem cells, as long as the cells are intended to perform only their normal function, according to Cell Stem Cell.

Scientists can harvest stem cells in different ways.

Embryonic stem cells come from an embryo that is just a few days old.

Scientists can extract adult stem cells from different types of tissue, including the brain, bone marrow, blood vessels, skeletal muscle, skin, teeth, the gut, the liver, among others.

Amniotic fluid contains stem cells. Many women opt for an amniocentesis test that checks for congenital disabilities before the child is born. If the doctor keeps the fluid, they could use it in the future to treat other conditions either during gestation or after birth.

Induced pluripotent stem cells (iPS cells) are cells that scientists can reprogram to act as stem cells, for use in regenerative medicine.

After collecting the stem cells, scientists usually store them in liquid nitrogen for future use.

Historically, the use of stem cells in medical research has been controversial.

This is because when the therapeutic use of stem cells first came to the publics attention in the late 1990s, scientists were deriving human stem cells from embryos.

Many people disagree with using human embryonic cells for medical research because extracting the stem means destroying the embryo.

This creates complex issues, as people have different beliefs about what constitutes the start of human life.

For some people, life starts when a baby is born, or when an embryo develops into a fetus. Others believe that human life begins at conception, so an embryo has the same moral status and rights as a human adult or child.

President George W. Bush had strong, pro-life religious views, and he banned funding for human stem cell research in 2001.

However, President Obamas administration allowed for a partial rolling back of these research restrictions.

However, by 2006, scientists had already started using pluripotent stem cells. Scientists do not derive these stem cells from embryonic stem cells. As a result, this technique does not have the same ethical concerns.

With this and other recent advances in stem cell technology, attitudes toward stem cell research are slowly beginning to change.

Stem cell research is helping scientists to understand how an organism develops from a single cell, and how healthy cells come to replace defective cells in people and animals.

Many severe medical conditions that occur in humans, such as cancer and congenital disabilities, happen because cells divide abnormally.

A better understanding of stem cells can provide insight into how these diseases arise and possible treatment options.

In June 2016, two researchers took second prize in the materials category of the United Kingdoms Royal Society of Chemistrys emerging technology competition for creating a synthetic biomaterial that stimulates stem cells native to a persons own teeth.

The researchers believe that this material will replace fillings, as the stem cells would prompt the damaged teeth to heal themselves.

Although much more research is necessary before stem cell therapies can become part of regular medical practice, the science around stem cells is developing all the time.

In almost every therapy area, doctors hope that stem cell technology will revolutionize therapeutic norms and introduce at least a new standard of personalized treatment, and maybe even self-healing bodies.

When that might happen, no one is quite ready to say.

Find out more here about stem cells, where they come from, and their possible uses.

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Stem cells: Therapy, controversy, and research

One upside of the coronavirus shutdown, maybe? Fewer voter initiatives – CALmatters

In SummaryInitiative proponents have until the end of April to collect the signatures they need to put their ideas on the ballot and with millions of Californians staying home, some campaigns won't have time to collect enough signatures.

California voters may experience a small silver lining amid the coronavirus pandemic: a shorter November ballot, featuring fewer of the statewide propositions that often put voters in the middle of confusing industry fights.

Initiative proponents have until the end of April to collect the signatures they need to put their ideas on the ballot and with millions of Californians staying home, and practicing social distancing when they go out, it may be impossible for some campaigns to collect enough signatures in time.

People arent out in public, and those who are out in public arent inclined to approach a stranger, take a pen, and stand within 6 feet to put something on the ballot, said Brian Brokaw, a Democratic political consultant who has been involved in several potential ballot measures.

Normally presidential election years attract a slew of initiatives, as campaigns particularly those pushing liberal ideas seek approval from a larger and more diverse electorate. Though we wont know until July exactly how many propositions will be on the ballot, it appears likely that it will be a lot less than in 2016, when Californians voted on 17 statewide ballot measures. Political insiders estimate the final number for 2020 will be in the range of six to 10.

Thats good news for election officials, who could face lower costs for printing and mailing shorter ballots, and for voters who may find the decision-making easier when faced with fewer proposals, said Kim Alexander, president of the nonprofit California Voter Foundation.

Sometimes voting in California can feel like youre taking a test voters can be intimidated by the length and complexity of the ballot, she said. So it could help encourage voter participation if we have fewer complex initiatives sprouting out of special-interest fighting.

People arent out in public, and those who are out in public arent inclined to approach a stranger, take a pen, and stand within 6 feet to put something on the ballot.

So far four measures have qualified for the November ballot, one measure has submitted signatures that are being verified, and another eight have collected at least 25% of the necessary signatures. (Depending on what type of law an initiative would change, it needs either about 623,000 valid signatures or about 997,000 valid signatures.)

Several campaigns have stopped collecting signatures because of the coronavirus shutdown, including those pushing initiatives to allow sports betting, tax plastic packaging to fund environmental programs, continue funding stem cell research and expand Californias data privacy law.

None of them are officially calling it quits. Some may already have enough signatures to make it on the ballot, while others are hoping they can resume collecting signatures in time to get more.

Because the health and wellbeing of Californians is foremost, we paused paid signature gathering efforts for the time being, said Jacob Mejia, a spokesman for the Pechanga Indian tribe that is backing the measure to permit sports betting. Tribal leadership remains committed to bringing this proposal to voters in November and are monitoring developments closely and assessing all options.

But the odds of getting back on the street with pens and clipboards any time soon seem slim, as Gov. Gavin Newsom has said the order to stay home to curb the spread of coronavirus may last two to three months.

Everything is on hold until its safe, said Dan Newman, a spokesman for the plastic recycling measure.

He said the campaign will try to get on the 2022 ballot if it cant resume gathering signatures very soon.

Newsom said this week that companies that are paid to gather signatures for ballot initiatives have asked him to extend the deadlines for submitting signatures so they can have more time to qualify for the November ballot. He was noncommittal, saying only that the question is one of many things hes processing in response to the pandemic.

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One upside of the coronavirus shutdown, maybe? Fewer voter initiatives - CALmatters

SENECA BIOPHARMA : MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K) – marketscreener.com

Our Management's Discussion and Analysis of Financial Condition and Results ofOperations or MD&A, is provided in addition to the accompanying financialstatements and notes to assist readers in understanding our results ofoperations, financial condition and cash flows. Our MD&A is organized asfollows:

Trends & Outlook - Discussion of what we view as the overall trends

important to understanding the assumptions and judgments incorporated in

our reported financial results and forecasts.

Results of Operations- Analysis of our financial results comparing the:

(i) year ended December 31, 2019 to the year ended December 31, 2018.

Liquidity and Capital Resources-Analysis of cash flows and discussion of

Our patented technology platform has three core components:

1. Over 300 lines of human, regionally specific neural stem cells, some of

which have the potential to be used to treat serious or life-threatening

diseases through direct transplantation into the central nervous system;

2. Proprietary screening capability - our ability to generate human neural

stem cell lines provides a platform for chemical screening and discovery of

3. Small molecules that resulted from Seneca's neurogenesis screening platform

We generated no revenues from the sale of our proposed therapies for any of theperiods presented.

We have historically generated minimal revenue from the licensing of ourintellectual property to third parties as well as payments under a settlementagreement.

Research and Development Expenses

We have a wholly owned subsidiary in the People's Republic of China thatprimarily oversees our current clinical trial to treat motor deficits due toischemic stroke.

General and Administrative Expenses

Critical Accounting Policies

Comparison of Our Results of Operations for the Years Ended December 31, 2019and 2018

Operating Expenses

Operating expenses for 2019 and 2018 were as follows:

Research and Development Expenses

General and Administrative Expenses

Other income (expense)

Other income, net in 2018 consisted of approximately $3,269,000 of non-cashgains related to the change in the fair value of our liability classified stockpurchase warrants and $79,000 of interest income.

Cash Flows - 2019 compared to 2018

Net Cash Used in Operating Activities

Net Cash Used in Investing Activities

There were no investing activities in the year ended December 31, 2019.

For the year ended December 31, 2018 cash provided by investing activities wascomprised primarily of proceeds from the maturity of our short-term investments.

Net Cash Provided by Financing Activities

For the year ended December 31, 2018, cash provided by financing activitiesconsisted primarily of approximately $1.8 million of net proceeds from ourOctober financing transaction.

Future Liquidity and Needs

Off-balance Sheet Arrangements

None.

Edgar Online, source Glimpses

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SENECA BIOPHARMA : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K) - marketscreener.com

Global Animal Stem Cell Therapy Market 2020 Growth Prospects Medivet Biologics LLC, Animal Cell Therapies, VETSTEM BIOPHARMA – NJ MMA News

The latest research report entitled Global Animal Stem Cell Therapy Market Growth 2020-2025 released by MRInsights.biz analyzes how the industry has been performing over the last few years and how it will achieve a high growth during the forecast period from 2020 to 2025. The report provides information, statistics, facts and figures, corporate intelligence, economic data, innovation drivers which supports the companies to maximize or minimize the production of goods depending on the states of demand. The report enfolds vital insights into the markets historical and ongoing trends that deliver reliable market estimates to help market players operate their business.

Market Introduction:

The report also highlights market scope, establishment, profitability, maturity, and growth prospects. The report carefully investigates the current scenario of the market and future estimations which spans several market dynamics. The research further explains industry statistics such as global Animal Stem Cell Therapy market size, present valuation, market share, industry trends, and the predicted revenue by the end of the projected period. Our analysts have discovered the business vertical that also explains the desirable growth rate of the market. Factors such as trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, and technological innovations are further discussed.

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If you are involved in the global Animal Stem Cell Therapy industry or intend to be, then this study will provide you comprehensive outlook. Its vital you keep your market knowledge up to date segmented by Medivet Biologics LLC, Animal Cell Therapies, VETSTEM BIOPHARMA, U.S. Stem Cell, Inc, VetCell Therapeutics, J-ARM, Kintaro Cells Power, Celavet Inc., Animal Stem Care, Magellan Stem Cells, Cell Therapy Sciences, Animacel

This report studies the global market status and forecast categorizes the global market size (value & volume) by key players, type, application, and region covering Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries)

Market segment by type covers: Dogs, Horses, Other

Market segment by applications can be divided into: Veterinary Hospitals, Research Organizations

Furthermore, the key entities analyzed and covered within the report includes a large type of applications, industry value and volume, market trends, utility ratio, demand and availability analysis, market growth outlook, manufacturing capacity and price ratio of the global Animal Stem Cell Therapy market during the estimated period from 2020 to 2025. Many inventive sales strategies are listed in the report. This may assistance is capturing numbers and enhancing business perception for the consumers. Segmentation studies include segment attractiveness and profitability. The latest market trends, dynamics, risks, and other influential factors are additionally discovered in the report.

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Global Animal Stem Cell Therapy Market 2020 Growth Prospects Medivet Biologics LLC, Animal Cell Therapies, VETSTEM BIOPHARMA - NJ MMA News

Cancer Stem Cell Therapy Value Projected to Expand by 2019-2025 – Monroe Scoop

In this report, the global Cancer Stem Cell Therapy market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2019 to 2025.

The Cancer Stem Cell Therapy market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Cancer Stem Cell Therapy market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

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The major players profiled in this Cancer Stem Cell Therapy market report include:

In global market, the following companies are covered:AVIVA BioSciencesAdnaGenAdvanced Cell DiagnosticsSilicon Biosystems

Market Segment by Product TypeAutologous Stem Cell TransplantsAllogeneic Stem Cell TransplantsSyngeneic Stem Cell TransplantsOther

Market Segment by ApplicationHospitalClinicMedical Research InstitutionOther

Key Regions split in this report: breakdown data for each region.United StatesChinaEuropean UnionRest of World (Japan, Korea, India and Southeast Asia)

The study objectives are:To analyze and research the Cancer Stem Cell Therapy status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.To present the key Cancer Stem Cell Therapy manufacturers, presenting the sales, revenue, market share, and recent development for key players.To split the breakdown data by regions, type, companies and applications To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.To identify significant trends, drivers, influence factors in global and regionsTo analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

In this study, the years considered to estimate the market size of Cancer Stem Cell Therapy are as follows:History Year: 2014-2018Base Year: 2018Estimated Year: 2019Forecast Year 2019 to 2025

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The study objectives of Cancer Stem Cell Therapy Market Report are:

To analyze and research the Cancer Stem Cell Therapy market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Cancer Stem Cell Therapy manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Cancer Stem Cell Therapy market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the keyword market.

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Cancer Stem Cell Therapy Value Projected to Expand by 2019-2025 - Monroe Scoop

Global Stem Cell and Gene Therapy Biological Testing Market (2019 to 2025) – Potential Growth Opportunities and Areas of Focus -…

DUBLIN--(BUSINESS WIRE)--The "Stem Cell and Gene Therapy Biological Testing Market, Size, Share, Outlook and Growth Opportunities 2019-2025" report has been added to ResearchAndMarkets.com's offering.

Stem Cell and Gene Therapy Biological Testing market outlook report presents key insights into global Stem Cell and Gene Therapy Biological Testing markets and companies with emphasis on market size, growth factors, R&D investments, market shares and 2019 market dynamics.

The report is structured to understand the key strategies of Stem Cell and Gene Therapy Biological Testing companies in terms of their investments, product portfolio, potential opportunities and future plans. The Stem Cell and Gene Therapy Biological Testing report provides 7-year outlook on market size across different Stem Cell and Gene Therapy Biological Testing types, applications, end-user industries and countries.

Scope of the report

Key Topics Covered:

1. Table of Contents

2. Global Stem Cell and Gene Therapy Biological Testing Industry Overview

2.1 Key Findings

2.2 Market Definition

2.3 Industry Overview

2.4 Report Guide and Research Methodology

3. Executive Summary

3.1 Key Trends Shaping the Future of Stem Cell and Gene Therapy Biological Testing Market to 2025

3.2 Key focus areas of Leading Manufacturers in the market

3.3 Potential Application Segments with strong growth prospects, 2019-2025

3.4 Key Emerging Markets vital for growth of Stem Cell and Gene Therapy Biological Testing Market

3.5 Prominent Types of Stem Cell and Gene Therapy Biological Testing set to Gain Market Shares, 2019-2025

4. Stem Cell and Gene Therapy Biological Testing Market Strategic Analysis Review

4.1 Porter's Five Forces Analysis of Global Stem Cell and Gene Therapy Biological Testing Market

4.2 Supply Chain Analysis of Stem Cell and Gene Therapy Biological Testing Industry

4.3 Pricing Analysis and Forecasts

4.4 SWOT Analysis

5. Global Stem Cell and Gene Therapy Biological Testing Market Outlook and Growth Opportunities

5.1 Global Stem Cell and Gene Therapy Biological Testing Market Outlook by Type, 2019-2025

5.2 Global Stem Cell and Gene Therapy Biological Testing Market Outlook by Application, 2019-2025

5.3 Global Stem Cell and Gene Therapy Biological Testing Market Outlook by Region, 2019-2025

6. Asia Pacific Stem Cell and Gene Therapy Biological Testing Market Outlook and Growth Opportunities

6.1 Introduction

6.2 Asia Pacific Stem Cell and Gene Therapy Biological Testing Market Outlook by Type, 2019-2025

6.3 Asia Pacific Stem Cell and Gene Therapy Biological Testing Market Outlook by Application, 2019-2025

6.4 Asia Pacific Stem Cell and Gene Therapy Biological Testing Market Outlook by Country, 2019-2025

6.5 Leading Companies

7. Europe Stem Cell and Gene Therapy Biological Testing Market Outlook and Growth Opportunities

7.1 Introduction

7.2 Europe Stem Cell and Gene Therapy Biological Testing Market Outlook by Type, 2019-2025

7.3 Europe Stem Cell and Gene Therapy Biological Testing Market Outlook by Application, 2019-2025

7.4 Europe Stem Cell and Gene Therapy Biological Testing Market Outlook by Country, 2019-2025

7.5 Leading Companies

8. North America Stem Cell and Gene Therapy Biological Testing Market Outlook and Growth Opportunities

8.1 Introduction

8.2 North America Stem Cell and Gene Therapy Biological Testing Market Outlook by Type, 2019-2025

8.3 North America Stem Cell and Gene Therapy Biological Testing Market Outlook by Application, 2019-2025

8.4 North America Stem Cell and Gene Therapy Biological Testing Market Outlook by Country, 2019-2025

8.5 Leading Companies

9. Rest of World (RoW) Stem Cell and Gene Therapy Biological Testing Market Outlook and Growth Opportunities

9.1 Introduction

9.2 Rest of World (RoW) Stem Cell and Gene Therapy Biological Testing Market Outlook by Type, 2019-2025

9.3 Rest of World (RoW) Stem Cell and Gene Therapy Biological Testing Market Outlook by Application, 2019-2025

9.4 Rest of World (RoW) Stem Cell and Gene Therapy Biological Testing Market Outlook by Country, 2019-2025

9.5 Leading Companies

10. Competitive Landscape

10.1 Leading Players

10.2 Market Shares of Top Companies in Revenue Terms, 2018

10.3 Company Benchmarking (Peer-to-Peer Comparison)

10.4 Financial Analysis

11. Business Profiles of Leading Stem Cell and Gene Therapy Biological Testing Companies

12. Stem Cell and Gene Therapy Biological Testing Market Recent News and Deals Landscape

12.1 Mergers and Acquisitions

12.2 Stem Cell and Gene Therapy Biological Testing Market New Product Launches

12.3 Asset Transactions

12.4 Financial Announcements

13. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/ol7uf2

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Global Stem Cell and Gene Therapy Biological Testing Market (2019 to 2025) - Potential Growth Opportunities and Areas of Focus -...

Non-Profit Offers Free Stem Cell Therapy to Veterans – Pain News Network

By A. Rahman Ford, PNN Columnist

No group is more worthy of the revolutionary benefits of stem cell therapy than Americas military veterans. While the U.S. Department of Veterans Affairs (VA) thinks the field is in its infancy and much more research is needed before stem cells are offered as treatment, brave practitioners are stepping forward to help veterans NOW.

Dr. Joseph Kanan and his staff at the Tullahoma Chiropractic Center are providing free stem cell therapy for veterans who suffer from chronic pain. Kanan in partnership with Veterans in Pain recently performed his first pro bono procedure on a veteran named Ryan, who has severe hip pain. Stem cell injections into Ryans hip, which are not covered by insurance, normally would have cost $6,500. Ryan got them for free.

I think veterans do a lot for our country and there are very few doctors that are performing medical procedures like this, Kanan told The Tullahoma News. We were very glad to be able to do this for him.

Kanan says his Tennessee clinic performs stem cell therapy for veterans twice a month and has had good results so far. One patient was able to avoid a knee replacement and reported consistent improvement one year after the procedure. Patients can expect to experience 10 percent improvement every month for 10 months.

Veterans in Pain is a non-profit that connects military veterans with civilian physicians who provide free regenerative medicine treatments for chronic pain. VIP has provided $250,000 worth of services since 2019.

VIP founder and president Micaela Bensko is herself a stem cell therapy recipient. She spent years in a wheelchair after an accident in her driveway left her with severe spine damage that led to arachnoiditis, a chronic inflammation of spinal nerves. A friend suggested stem cell therapy, which inspired Bensko to establish VIP as a resource for veterans.

Veterans in Pain connects each veteran with a volunteer physician in their area. If one cannot be located, the cost of transportation and accommodations are covered for treatments, as they were for Ryan. Veterans associated with VIP visit schools, organizations and corporations sharing their story of recovery. Most of VIPs funding is provided by small individual donations, grants and grassroots fundraising.

According to the National Institutes of Health, nearly two-thirds of veterans report having chronic pain, with about 9% having severe pain. Chronic pain among veterans is closely associated with mental health conditions such as depression, anxiety, poor sleep and substance abuse disorders. Many veterans suffer from more than one condition.

Because of red tape and a shortage of pain management specialists at the VA, many veterans suffering from chronic pain are left devoid of proper diagnosis and treatment, causing many to self-medicate or search for answers on their own.Chronic pain can lead to substance abuse, a common and growing trend among veterans. A 2017 study found that 30% of military suicides were preceded by alcohol or drug abuse.

The dire plight of military veterans suffering from chronic pain is yet another compelling reason for the FDA to loosen its regulation of stem cell therapy. Our heroes are counting on it.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatmentin China.

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Non-Profit Offers Free Stem Cell Therapy to Veterans - Pain News Network

Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations – Yahoo Finance

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

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

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Story continues

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

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 therapy. We are leveraging 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. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Yahoo Finance

A new way to study HIV’s impact on the brain – Penn: Office of University Communications

Though many negative repercussions of human immunodeficiency virus infection can be mitigated with the use of antiretroviral therapy (ART), one area where medical advances havent made as much progress is in the reduction of cognitive impacts. Half of HIV patients have HIV-associated neurocognitive disorders (HAND), which can manifest in a variety of ways, from forgetfulness and confusion to behavior changes and motor deficiencies.

To better understand the mechanisms underlying HAND, researchers from Penns School of Dental Medicine and Perelman School of Medicine and from the Childrens Hospital of Philadelphia (CHOP) brought together their complementary expertise to create a laboratory model system using three of the types of brain cells thought to be involved. Led by doctoral student Sean Ryan, who was co-mentored by Kelly Jordan-Sciutto of Penn Dental Medicine and Stewart Anderson of CHOP and Penn Medicine, the model recapitulates important features of how HIV infection and ART affect the brain.

Frankly the models we generally use in the HIV field have a lot of weaknesses, says Jordan-Sciutto, co-corresponding author on the paper, which appears in the journal Stem Cell Reports. The power of this system is it allows us to look at the interaction between different cell types of human origin in a way that is more relevant to patients than other models.

In addition to studying HIV, members of the team plan to use the same model to shed light on the neurological mechanisms that underlie other conditions, such as schizophrenia, Alzheimers, and even normal aging.

Were collaborating with a variety of colleagues to use this system to study Alzheimers disease as well as schizophrenia, says Anderson, co-corresponding author on the paper. We have the components in a dish that we know are interacting in these diseases, and this gives us a new mix-and-match way to understand how certain cells are contributing to neuronal damage.

Indeed, the impetus to create the model grew not out of HIV research but work that Ryan was pursuing in Andersons lab on schizophrenia.

We had been looking at the role of microglia, the resident immune cells of the central nervous system, says Ryan, first author on the work. We wanted to see if we could see the mechanistic changes that occur with microglia in schizophrenia.

To do so, Ryan and Anderson were interested in using human-induced pluripotent stem cellsadult cells that are reprogrammed to resemble embryonic stem cellswhich can be coaxed into differentiating into a variety of different cell types.

But schizophrenia is a complicated disease with a variety of contributing genetic and environmental factors and a broad spectrum of presentations. Rather than looking at something complex, they sought to apply their new system to a disease that likewise causes neurological damage but does so in a more dramatic way and in which microglia are also implicated: HIV/AIDS infection.

They reached out to Jordan-Sciutto, who has deep experience investigating the mechanisms of HAND and was eager for the opportunity to develop a model superior to those currently available. Together, the scientists identified the three cell types they were most interested in studying: neurons, astrocytes, and microglia.

Neurons arent directly infected by HIV but are known to be damaged during infection. Meanwhile astrocytes are believed to interact with neurons, causing damage by sending pro-inflammatory factors into the spaces between cells, called synapses. And microglia, which are responsible for maintaining a healthy environment in the absence of disease, are seen to expand and contribute to inflammation during HIV infection.

After nailing the technical challenge of creating this tractable model in which each cell type is generated independently and then mixed together, the team used it to probe how HIV infection and ART impact the cells, both alone and in combination.

A lot of people are taking PreEP [pre-exposure prophylaxis] if theyre in a situation where their risk of contracting HIV is heightened, says Ryan. Just as we want to understand the cognitive impacts of HIV, we also want to see whether these drugs alone are impacting the brain health of otherwise healthy people.

The researchers looked at RNA expression in their cultures to get a sense of what proteins and signaling pathways were becoming activated in each scenario. During infection, they saw inflammatory pathways that had previously been implicated in HIV in earlier research. When they introduced the antiretroviral drug EFZ, which is not in common use in the United States but remains a frontline therapy in many other areas of the world, with an infection, the activity of most of these pathways was reduced.

But this scenario involved its own unique response, says Ryan. Certain pathways associated with inflammation and damage remained despite the introduction of EFZ.

EFZ treatment of the tricultures that included HIV-infected microglia reduces inflammation by around 70%, Ryan says. Interestingly, EFZ by itself also triggered inflammation, though to a lesser extent than infection.

It seems a combination of infection and ART is creating its own unique response that is different from the sum of its parts, Ryan says. Knowing what pathways are still active due to ART could help us appropriately target additional therapies so patients dont develop HAND.

Many features of infection seen in the three-cell culture mirror what is known from HIV infection and ART treatment in people, giving the researchers confidence in the reliability of their model.

Just looking at the microglia, says Anderson, we see in our system that they are taking on both of their normal roles in keeping key signaling systems balanced during their normal state and activating and causing damage when theyre fighting infection. Were able to model normality and abnormality in a way we havent been able to before.

For Jordan-Sciutto, the new system is really going to change the way my lab operates going into the future. Shes hopeful many other HIV scientists will take it up to further their studies as she also explores more aspects of HIVs impact on the brain, such as how it navigates through the blood-brain barrier that normally protects the central nervous system from inflammation and infection.

The study authors give credit to the collaborative environment at Penn for this cross-disciplinary project. Tentacles of this project extend from CHOP to the dental school to the vet school to the medical school, says Anderson. Penn is a very special place where people seem to be more likely to share their technologies around and let other people work with and develop them. This project is a great example of that.

Kelly L.Jordan-Sciutto is vice chair and professor in the Department of Basic and Translational Sciences in Penns School of Dental Medicine, associate dean of graduate education, and director of biomedical graduate studies at the Perelman School of Medicine.

Stewart A. Anderson is director of research in the Department of Child and Adolescent Psychiatry and Behavioral Services at the Childrens Hospital of Philadelphia and a professor of psychiatry at the Perelman School of Medicine.

Sean K. Ryan was a graduate student in Penns Cell and Molecular Biology Graduate Group in the Genomics and Epigenetics program, co-mentored by Jordan-Sciutto and Anderson. He is now a postdoctoral researcher at the Perelman School of Medicine.

Jordan-Sciutto, Anderson, and Ryans coauthors on the study were CHOPs Michael V. Gonzalez, James P. Garifallou, Nathaniel P. Sotuyo, Kieona Cook, and Hakon Hakonarson; Penn Medicines Frederick C. Bennett and Eugene Mironets; and Spelman Colleges Kimberly S. Williams.

The research was supported by the National Institute of Neurological Disorders and Stroke (Grant NS107594), Penn Center for AIDS Research, and Penn Mental Health AIDS Research Center.

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A new way to study HIV's impact on the brain - Penn: Office of University Communications

Kalytera Therapeutics: improving bone marrow transplants with CBD – Health Europa

The development of bone marrow transplantation procedures is widely considered one of the greatest victories in the war against cancer. The vast majority of bone marrow transplant recipients are patients with various forms of blood cancers, such as leukaemia, lymphoma or multiple myeloma. A real game changer, bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to over 85%.

Unfortunately, however, patients receiving bone marrow transplants are at high risk of developing Graft versus Host Disease (GvHD), a life-threatening complication that occurs when the transplanted cells from the donor the graft identify the transplant recipient the host as foreign.

This triggers an immune reaction that can wreak havoc in the transplanted patients body as it is attacked by the donated cells. This can occur from just days (in the case of acute GvHD) up to months or years (for chronic GvHD) after the haematopoietic cell transplantation (HCT) procedure has taken place.

The mortality rate of acute GvHD is very high in the case of grade 4 GvHD, it is over 90%. The overwhelmingly positive preliminary response of patients to CBD in preventing and treating GvHD shown in early trials, could be the key to significantly decreasing the incidence of this terrible condition.

Before we go on, there is a distinction to be made between a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue, as may be the case in liver or heart transplants, and GvHD, which occurs when the while blood cells in the donors reject the recipient.

There are two types of bone marrow transplant: autologous (from the patients own stem cells) and allogeneic (stem cells from a donor). It is in the latter where GvHD may occur.

GvHD from allogeneic bone marrow transplants can manifest itself in many forms and degrees; ranging from mild, moderate or severe, to potentially fatal for the patient. Acute GvHD can cause rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhoea, jaundice; and may attack the lungs, liver and eyes. It is often associated with chronic illness, infections, disability, reduced quality of life, and is a major cause of morbidity and mortality following HCT.

Researchers estimate that despite aggressive preventive measures with immunosuppressive treatments, 30% to 50% of transplanted patients whose donors were fully matching siblings and 50% to 70% of patients whose donors were unrelated to them develop some level of GvHD.

Though it may sound surprising, currently there are no FDA approved therapies for either the prevention or treatment of acute GvHD.

Enter Kalytera Therapeutics, a clinical-stage pharmaceutical company aiming to develop cannabidiol (CBD) for the treatment of serious diseases. The companys drug development expertise and intellectual property portfolio put it at the forefront in the development of CBD-based medicines for a range of important unmet medical needs. Currently, its resources are being focused mainly on mitigating the effects of GvHD following bone marrow transplantation.

Kalytera Therapeutics lead programme, in which we are evaluating CBD for the prevention and treatment of GvHD, is in late-stage clinical testing. Kalytera Therapeutics have an ongoing open label Phase 2 clinical study to evaluate the pharmacokinetic profile, safety and efficacy of CBD for the prevention of acute GvHD with encouraging preliminary results; we are currently approaching the end of cohort 2. A series of Phase 1 studies requested by the FDA, such as the effect of food intake on the absorption of oral CBD, have also been completed.

At this stage, Kalytera Therapeutics are ready to plan a meeting with the FDA to discuss the possibility of starting a pivotal study later this year. Following the approval of Epidiolex for Dravet Syndrome by GW Pharma, the FDA has encouraged that Kalytera apply for a 505(b)2 regulatory pathway, which provides manufacturers of some types of drugs to apply for FDA approval without performing all the work required in a new drug application.

Kalytera Therapeutics have also received a Fast Track Designation to aid in the development and expedite review of drugs intended for serious or life-threatening disease and addressing an unmet medical need, for the companys CBD products for prevention and treatment of acute GvHD. This could accelerate the approval process for these products.

The obvious first step in attempting to prevent GvHD is to find donor cells that match the genetics of the immune system of the transplant recipient as closely as possible. But even in the ideal case of the donors being a sibling, the patient still must rely on drugs specially developed to cause immunosuppression of the donor cells, through either T-cell depletion or drugs. Treatments usually used for this include methotrexate, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil and antithymocyte globulin (ATG), as determined by each medical team and institution.

When it comes to treating GvHD, the grafts immune cell activation needs to be suppressed with medication, so that donor-host immune tolerance can be established once again. Most patients are given corticosteroids, which directly suppress the donors immune cell attack on the hosts tissues. This also raises the risk of infection and the relapse of cancer.

As of now, there are guidelines but there is no standard treatment for either prevention or treatment of acute GvHD. Only 30% to 50% of patients with moderate to severe GvHD respond to corticosteroids, leaving many at risk of fatal outcomes. Everyone in the healthcare system should be aware that more research is necessary to discover better treatment options to reduce the rates of mortality and morbidity in transplantation patients.

The programme Kalytera is now implementing is based on previous Phase 2a clinical trials, which showed outstanding preliminary results in the prevention of the disease by giving patients CBD orally. In the first study, 48 patients received CBD for seven days prior to the bone marrow transplant procedure and for 30 days thereafter, as opposed to a group of 101 historical controls who had been given the usual GvHD prophylaxis and treated in the same BMT unit by the same medical team.

Remarkably, results showed none of the 48 patients had developed acute GvHD in the 30 days of treatment with CBD. Those who developed GvHD did so within a median time of 60 days, whereas the control group of 101 historical controls began to develop acute GvHD in a median time of 20 days only (ranging from nine to 137).

In the CBD treated group, the rates of grade 2 to grade 4 acute GvHD by day 100 were 12.1%, compared with 46% in the control. The rate of severe grade 3 to grade 4 was 5%, compared to 10% in the control. Equally important is the finding that CBD was also safe and well tolerated, with no severe adverse events attributed to its consumption. This is consistent with safety data previously reported on CBD administered to humans, even with three to four times higher doses and even when taken over extended periods of time.

In light of these encouraging initial results, it was decided to test the efficacy of a prolonged treatment covering 100 days: the time window in which acute GvHD usually occurs. In a second study, 12 patients were administered CBD at the same dose starting from seven days before the bone marrow transplant procedure until 100 days post-transplantation. No safety issues were observed here either and only one noncompliant patient, representing 8% of the CBD treatment group, developed acute GvHD; compared to a 46% incidence at the same institution in the historical group of 101 patients described above. This is despite the fact that the majority of the patients (10 out of 12) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors, which would normally increase their chance of developing GvHD.

In a third Phase 2a study, which was performed for treatment of already sick patients, 10 patients with acute GvHD, who were refractory to standard treatment with high dose steroids (only 60% of patients respond to first line therapy with high dose steroids), were administered daily doses of CBD for up to three months. Strikingly, nine of the 10 patients enrolled in the study responded to treatment, seven of them achieving complete remission of GvHD and two more achieving a near-complete response.

These results are impressive when we take into account that the 12-month mortality rate among patients with grade 3 and grade 4 GvHD who do not respond to steroids exceeds 60% and 80%, respectively. Indeed, these preliminary results compare favourably with the results of the historical control group of 29 patients with steroid-refractory grades 3 and 4 GvHD, among which 26 patients died from GvHD and its complications.

With a median follow-up period of 13 months, six patients were still alive. Two patients died from leukaemia relapses, and two patients died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment. This underlines the urgency of developing a product that can prevent and treat GvHD.

On the list of the 10 most expensive medical procedures, allogeneic BMT ranked fourth; while autologous BMT, at less than half the outrageous cost, still made it to the eighth place. Depending on the country and institution, costs range from tens of thousands to hundreds of thousands of dollars per procedure. The need and incentive to increase the rate of success are indisputable.

The life-saving ability of Kalyteras CBD products for the prevention and treatment of acute GvHD, currently classified as an orphan disease, means the company has good chances of obtaining premium pricing for a course of treatment. Over 20,000 patients suffer from acute GvHD following bone marrow transplantation in the six major markets of the US, Germany, the UK, France, Spain and Japan every year.

According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential market for a successful drug for prevention and treatment of GvHD in the seven major jurisdictions of the US, Germany, France, Italy, Spain, the UK and Japan is estimated to be over $408m in 2018; and could grow to approximately $1.3bn by 2027.

Once Kalyteras CBD products are approved by the FDA, the company believes that treating physicians would not be expected to prescribe anything other than its approved formulation of CBD (as opposed to a non-approved CBD that might be available online or from other commercial sources), especially since patients are often in isolation in the intensive care unit. It is safe to assume that neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD in the jurisdictions where Kalytera intends to market its CBD product.

Conducting proper, large scale clinical trials with CBD is of utmost importance. Although in some areas CBD seems to be generally safe in the broader healthy population, it can be harmful to some groups, such as young adults, women of childbearing age, pregnant women, children, people with known heart conditions or low blood pressure, and the elderly.

Despite all the hype about the multiple health benefits of cannabis-based products trumpeted by many (though not clearly stated due to possible risks of liabilities for unsubstantiated claims), so far only one CBD-based drug has received FDA approval for the treatment of two rare and serious types of epilepsy.

Contrary to popular belief and anecdotal evidence, CBD is not a biologically inert compound. Rather, CBD has a complex pharmacokinetic and pharmacodynamic profile similar to any other medication with the potential to interact with other medications and medical conditions. CBD is metabolised in the liver by enzymes responsible for metabolising a large percentage of other drugs. When taken concomitantly, CBD may reduce or neutralise the intended action of those other medications. Kalytera has completed drug to drug interaction testing in vitro and is now planning to start testing in healthy subjects.

CBD oil can have negative side effects too, such as drowsiness, drop in blood pressure when taken in large doses, being potentially harmful for people with low blood pressure. Other problems are dizziness or light-headedness, appetite changes, diarrhoea, hormonal changes, hypokinesia and resting tremor when used for epilepsy. In psychotic disorders it has side effects too, but they are milder than on other drugs used until today. It can benefit some Parkinsons patients, but not all of them.

Kalytera has a solid, experienced leadership team and very strong intellectual property portfolio. We have three issued US and European patents covering the use of CBD in the prevention and treatment of GvHD, as well as four orphan drug designations for the treatment and prevention of GvHD in the US and Europe.

Our promising preliminary results indicate we will be able to help BMT patients and their donated bone marrow get along better. This will greatly improve patients quality of life, productivity and life expectancy by keeping them GvHD free.

Dr Sari SagivStero Biotechs+972 36176173david@sela.co.il

Please note: Kalytera Therapeutics Inc. have recently acquired Stero Biotechs.

This article will appear in the second issue ofMedical Cannabis Network which will be available to read in April 2020.

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Kalytera Therapeutics: improving bone marrow transplants with CBD - Health Europa