Stem Cell Clinic

Cellect’s Novel Technology Isolates Therapeutic Stem Cells for Regenerative Medicine – Digital Journal (press release)

This press release was orginally distributed by SBWire

New York, NY -- (SBWIRE) -- 06/27/2017 -- Stem cell therapy, a way to replace damaged tissues through regenerative medicine, holds hope for patients everywhere. However, aside from very few applications, cell therapy has not made the leap from laboratory to market. One of the major hurdles have been a cost-effective way of achieving purified stem cells. A big challenge in cell therapy has been separating mature donor cells, which can cause severe damage to the patient, from the donor's stem cells which heal through regenerative medicine. Cellect Biotechnology Ltd., developer of a novel stem cell collection technique, has an effective and elegant technology for harvesting stem cells.

A key component of Cellect's platform technology, ApoGraft, is the ApoTainer which uses cell suicide inducing proteins to kill older cells through apoptosis, or programmed cell death. Cellect has discovered that in an apoptotic environment, mature cells die, while stem cells survive and thrive. The cell selection process is quick, just hours, and the result is a rich, non-toxic batch of stem cells ready to be implanted.

In its first indication, Cellect is evaluating its technology in allogenic (donor) bone marrow transplant (BMT) where up to 50% of patients suffer graft-versus-host disease (GvHD) under current methods, often leading to sickness and death. With the right stem cell procedure, GvHD can be reduced and potentially eliminated.

BMT, a procedure fraught with the chance for GvHD because of its mix of old cells that trigger rejection of tissue implants, is Cellect's initial indication. Cellect demonstrated success in its first stem cell transplant in March using ApoGraft in BMT in its Phase I/II trial, leading to the independent Data and Safety Monitoring Board's (DSMB) approval to continue patient enrollment. A total of 12 patients suffering from blood cancer will be treated, with an eye on efficacy and safety in preventing GvHD.

75,000 BMTs are performed in the US annually at an average cost of $800,000 per transplant, resulting a $60 billion market that is growing due to an aging population and is mainly limited by the GvHD.

Currently, stem cells are either sourced from the patient (autologous) prior to undergoing high-dose chemo or radiation therapy, or they are harvested from donor (allogeneic) stem cells. Chances for perfect donor match for blood cancer patients undergoing BMT are only 25% not good odds. Allogenic donors are subject to an intensive and long procedure including rigorous physical exams, blood samples taken in up to four separate appointments, time commitment of 30 hours spread over four to six weeks, and travel expense.

Both autologous and allogeneic methods can be hazardous because of the combined mix of old cells and vital stem cells that have a better chance to avoid GvHD. This is standard medicine, and not an optimal solution. Cellect's technology eliminate the non-matched immune response carrying cells . Time and money can be saved.

Operating under a well-thought out business model, Cellect plans to out-license its ApoGraft platform to pharma, biotech, research centers and hospitals, furnishing them with an unprecedented tool. Non-exclusive licensing gives Cellect a broad array of potential partners.

Cellect's robust intellectual property protection includes patents that cover all aspects of selecting only the cells needed for the transplantation, with the promise of avoiding GvHD. Yet Cellect's platform is not only for blood cancers. Other future applications can be directed to autoimmune disease such as Juvenile diabetes, all significant markets.

Cellect has drawn leaders in key areas important to further regenerative medicine into mainstream treatment options. Scientific and medical advisors include researchers and practitioners from Dana Farber, Harvard, King's College London, Pfizer Inc., the FDA, and Stanford. All have a deep interest in making stem cell therapy a reality. All will be critical to advising the company on current and future regulatory pathways. All strongly believe in Cellect's technology.

At the end of the first quarter of 2017, Cellect had cash of approximately $7 million. With the stock trading at about $8.50, the market cap is $45 million.

If the Phase I/II study proves successful, Cellect will be well positioned to partner with pharma and biotech firms who will use the ApoGraft platform in whichever applications they wish, giving Cellect an opportunity for ongoing revenue from licensing and royalties. This could boost its cash levels, stock price and market cap.

Cellect leads the world in providing a pioneering method to harvest stem cells that seek to cure many diseases, starting with proof in BMT, without adverse side effects. Its goal is to make ApoGraft available for clinics to use easily and effectively, much like any modern-day medical tool. Its technology is both simple and revolutionary, making stem cell medicine a nearer-term reality than ever before.

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About Ray Dirks Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally.

In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, "The Great Wall Street Scandal" and "Heads You Win, Tails You Win," published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.

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Cellect's Novel Technology Isolates Therapeutic Stem Cells for Regenerative Medicine - Digital Journal (press release)

askST: Is stem cell therapy available in Singapore? – The Straits Times

Reader Charles Wang wrote in to ask if stem cell therapy is approved for use in Singapore. Stem cell therapy refers to the use of stem cells to treat various medical conditions. Mr Wang also asked if it is available, and where one can seek this treatment.

Health reporter Linette Lai answered.

Any new treatment must be backed by sufficient scientific evidence to ensure that it is safe and effective. However, there is not enough scientific evidence yet for stem cell therapy to be approved as a mainstream treatment in Singapore.

There is not enough scientific evidence yet to ensure that stem cell therapy is safe and effective for it to be approved as a mainstream treatment in Singapore. PHOTO: ST FILE

A Health Ministry spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments and is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it will have to be conducted within the context of clinical trials."

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askST: Is stem cell therapy available in Singapore? - The Straits Times

Cell Therapy Manufacturing Market Report 2017 – Strategies for … – Business Wire (press release)

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "The Market For Cell Therapy Manufacturing - Strategies for Pricing, Cost Control, Reimbursement, Distribution, & More" report to their offering.

This global strategic report provides detailed analysis of ten leading cell therapy companies worldwide, evaluating the strengths of each company, as well as identifying cell therapy products in development, manufacturing strategies, and partnerships.

The report analyzes time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing.

Additionally, the report identifies cell therapy products that have been reviewed and approved by internationally-recognized regulatory agencies, as well as products brought to market in the U.S. with FDA approval. It also specifies which cell therapies have since been pulled from market, due to factors such as low adoption rates, unsuccessful reimbursement strategies, or high cost of manufacturing.

It provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent FDA guidelines for Human Cell and Tissue-based Products (HCT/Ps) and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in Japan, including the:

- Act on the Safety of Regenerative Medicine (Law No. 85/2013)

- Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013)

Key Topics Covered:

1. Introduction to Cell Therapy Manufacturing

2. Leading Cell Therapy Companies

3. Approved Cell Therapy Products

4. Pricing Analysis for Cell Therapy Products

5. Cost-Control for Cell Therapy Products

6. Time Frames for Cell Therapy Product Development

7. Reimbursement of Cell Therapy Products

8. Distribution Channels for Cell Therapy Products

9. Market Trend Analysis - Key Trends Impacting the Marketplace

10. Technologies Impacting the Cell Therapy Manufacturing Market

11. Market Potential for Autologous vs. Allogeneic Manufacturing

12. Cell Therapy Manufacturing Challenges and Considerations

13. Conclusions

Cell Therapies Mentioned:

- Apligraf (Organogenesis, Inc. & Novartis AG)

- Carticel (Genzyme)

- Cartistem (MEDIPOST)

- ChrondoCelect (TiGenix NV)

- Cupistem (Anterogen)

- Dermagraft (Advanced Tissue Sciences)

- Epicel (Vericel)

- Hearticellgram-AMI (FCB Pharmicell)

- Holoclar (Chiesi Farmaceutici)

- Osteocel (NuVasive)

- Prochymal (Mesoblast)

- Provenge

- Strimvelis (GSK)

- TEMCELL (JCR Pharmaceuticals Co. Ltd., Licensee of Mesoblast Ltd.)

For more information about this report visit https://www.researchandmarkets.com/research/rspfrk/the_market_for

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Cell Therapy Manufacturing Market Report 2017 - Strategies for ... - Business Wire (press release)

Regenerative Medicine Pioneer Offers Comprehensive Stem Cell Training – PR Web (press release)

Dr. Purita has been a pioneer in the Regenerative Medicine space for over a decade.

Boca Raton, Florida (PRWEB) June 27, 2017

Robert J. Colucci CEO of PuRxCell, LLC announced today that PuRxCell, a Florida based company, has been established to train physicians at all levels of experience and their staffs in Dr. Puritas unique Stem Cell treatment and processing protocols. PuRxCell also provides a comprehensive line of products to support these cutting edge protocols.

Dr. Purita has been a pioneer in the Regenerative Medicine space for over a decade, said CEO R.J. Colucci. He continued, He has performed more than 8500 treatment procedures without serious adverse effect. These unique protocols not only improve treatment outcomes but also significantly reduce the cost of the treatment and increase margins, which is important in the world of increasing competition and reduced insurance reimbursements. Colucci said, Our mission at Purxcell is simple: Deliver individualized training to physicians - offer cutting edge treatment and processing protocols and products - lower the cost of treatment and provide physicians and their staffs a continuum of training and support."

In my 35 years as an Orthopedic Surgeon, I have never been as excited as I am over the advancements in Regenerative Medicine. Over the last 10 years I have focused my efforts on developing and refining cutting edge PRP and Stem Cell procedures and adjunct therapies, said Joseph Purita, PuRxCells Chief Medical Officer.

Purita continued, I have been hesitant to pass on specific details about my experiences and unique protocols. However, I have come to the conclusion that I want some of my colleagues and ultimately their patients to benefit from what I have learned. As such, PuRxCell is offering direct physician training as well as access to my proprietary treatment protocols and products. Purita noted, I was also unhappy with the current costs of disposable products for Stem Cell treatment protocols. I have expended considerable effort to finding ways to lower procedure and disposable costs while at the same time improving the quality of patient outcomes. All this eventually led me to form a dedicated, full service Regenerative Medicine company, PuRxCell. We have developed blood, adipose and bone marrow processing products designed to help customers dramatically reduce cost without sacrificing treatment outcomes.

Founded in 2016, Purxcell has multiple level of training programs tailored to individual physicians needs and experience levels. Physician training ranges from 2-5 days, while training for lab staff typically ranges from 1-2 days. PuRxCell also offers Regenerative Medicine practice and marketing support in line with the mission of providing full-service Regenerative Medicine products and services.

PuRxCell has its corporate headquarters office in Boca Raton, Florida, with satellite offices in Colorado and Coconut Creek, FL. More information about PuRxCell can be found at http://www.purxcell.com.

For additional information contact: Robert Colucci at r.colucci(at)purxcell(dot)com or at 877-498-5500 ext. 1

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Regenerative Medicine Pioneer Offers Comprehensive Stem Cell Training - PR Web (press release)

Single-cell Analysis Market to Reach $3.5 Billion by 2022 – Due to Increasing Government Funding For Cell-Based … – PR Newswire (press release)

The single-cell analysis market is expected to reach USD 3.59 Billion by 2022 from USD 1.67 Billion in 2017, at a CAGR of 16.5%.

Technological advancements in single-cell analysis products, increasing government funding for cell-based research, growing biotechnology and biopharmaceutical industries, wide applications of single-cell analysis in cancer research, growing focus on personalized medicine, and increasing incidence and prevalence of chronic and infectious diseases are the major factors driving the growth of the market. The report segments the market into product, cell type, technique, application, end user, and regions.

On the basis of product, the market is segmented into consumables and instruments. In 2017, the consumables segment is expected to account for the largest share of the single-cell analysis market. This segment is also expected to register the highest CAGR during the forecast period. The growth of this segment is attributed to the requirement of frequent and repeat purchase of these products as compared to instruments, which are considered as a one-time investment.

The single-cell analysis market, by cell type is segmented into human, animal, and microbial cells. In 2017, human cells segment is expected to account for the largest share of the market. The growing application areas of human stem cells and rising incidence of diseases such as cancer are the major factors driving the growth of this segment.

Based on the technique, the market is segmented into flow cytometry, NGS, PCR, microscopy, mass spectrometry, and other techniques (including single-molecule fluorescence in situ hybridization, micromanipulation, and automated capillary electrophoresis). In 2017, flow cytometry is expected to account for the largest share of the single-cell analysis market. The large share of the flow cytometry segment can primarily be attributed to the wide usage of flow cytometry in single-cell analysis applications.

Companies Mentioned

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Single-Cell Analysis Market, By Product

7 Single-Cell Analysis Market, By Cell Type

8 Single-Cell Analysis Market, By Technique

9 Single-Cell Analysis Market, By Application

10 Single-Cell Analysis Market, By End User

11 Single-Cell Analysis Market, By Region

12 Competitive Landscape

13 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/research/762rc6/singlecell

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/single-cell-analysis-market-to-reach-35-billion-by-2022---due-to-increasing-government-funding-for-cell-based-research--growing-focus-on-personalized-medicine---research-and-markets-300479506.html

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Single-cell Analysis Market to Reach $3.5 Billion by 2022 - Due to Increasing Government Funding For Cell-Based ... - PR Newswire (press release)

Alzheimer’s disease risk linked to a network of genes associated with myeloid cells – Medical Xpress

June 26, 2017 PET scan of a human brain with Alzheimer's disease. Credit: public domain

Many genes linked to late-onset Alzheimer's disease (AD) are expressed in myeloid cells and regulated by a single protein, according to research conducted at the Icahn School of Medicine at Mount Sinai and published June 19 in the journal Nature Neuroscience.

Mount Sinai researchers led an international, genome-wide study of more than 40,000 people with and without the disease and found that innate immune cells of the myeloid lineage play an even more central role in Alzheimer's disease pathogenesis than previously thought.

Specifically, the research team identified a network of genes that are implicated in AD and expressed by myeloid cells, innate immune cells that include microglia and macrophages. Furthermore, researchers identified the transcription factor PU.1, a protein that regulates gene expression and, thus, cell identity and function, as a master regulator of this gene network.

"Our findings show that a large proportion of the genetic risk for late-onset AD is explained by genes that are expressed in myeloid cells, and not other cell types," says Alison Goate, DPhil, Professor of Neuroscience and Director of The Ronald M. Loeb Center for Alzheimer's Disease at the Icahn School of Medicine at Mount Sinai and principal author of the study. "Dysregulation of this network is certainly a cause of Alzheimer's, but we have more work to do to better understand this network and regulation by PU.1, to reveal promising therapeutic targets."

Using a combination of genetic approaches to analyze the genomes of 14,406 AD patients, and 25,849 control patients who do not have the disease, researchers found that many genes which are known to influence the age at which AD sets in, are expressed in myeloid cells. This work pinpointed SPI1, a gene that encodes the transcription factor PU.1, as a major regulator of this network of AD risk genes and demonstrated that lower levels of SPI1/PU.1 are associated with later age at onset of AD.

To test the hypothesis that SPI1 expression levels influence expression of other AD risk genes and microglial function, the researchers used a mouse microglial cell line, BV2 cells that can be cultured in a dish. When researchers knocked down expression of SPI1, the gene that produces PU.1 in cells, they found that the cells showed lower phagocytic activity (engulfment of particles), while overexpression of SPI1 led to increased phagocytic activity. Many other AD genes expressed in microglia also showed altered expression in response to this manipulation of SPI1 expression.

"Experimentally altering PU.1 levels correlated with phagocytic activity of mouse microglial cells and the expression of multiple AD genes involved in diverse biological processes of myeloid cells," says Dr. Goate. "SPI1/PU.1 expression may be a master regulator capable of tipping the balance toward a neuroprotective or a neurotoxic microglial function."

The researchers stress that because the PU.1 transcription factor regulates many genes in myeloid cells, the protein itself may not be a good therapeutic target. Instead, further studies of PU.1's role in microglia and AD pathogenesis are necessary, as they may reveal promising downstream targets that may be more effective in modulating AD risk without broad effects on microglial function. Increased understanding is crucial to facilitating the development of novel therapeutic targets for a disease that currently has no cure.

Explore further: Phagocytes in the braingood or bad?

More information: Kuan-lin Huang et al. A common haplotype lowers PU.1 expression in myeloid cells and delays onset of Alzheimer's disease, Nature Neuroscience (2017). DOI: 10.1038/nn.4587

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Alzheimer's disease risk linked to a network of genes associated with myeloid cells - Medical Xpress