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Category Archives: Cell Therapy

Cell Therapy Blog – blogspot.com

Posted: Published on October 28th, 2014

Despite us both living in the Vancouver area and both being involved in cell therapy, I didn't meet David Hall until we were both in La Jolla late last year for the Alliance for Regenerative Medicine's Stem Cell on the Mesa meeting. Since then we've been keeping in close contact and I have had opportunity to learn a lot more about him,his team,RepliCel, and the company's technology. David presents a sound logic for the transitions through which he has taken the company in the past 18 months and the pace of that change. He does, perhaps more than many CEO's I have had the opportunity to interview, present a strong and focused vision for the company with a clear goal and a well-defined pathway for how he intends to get the company there. From my vantage point, this vision permeates into most aspects of the company from clinical trial design, to patent strategy, to defining collaborations, and even recruiting. Suffice it to say I have been increasingly impressed by what I see and welcome the opportunity to share the interview below with you. I hope you enjoy learning a little more about RepliCel as much as I have. CTB: Tell … Continue reading

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Current Trends in Cell Therapy

Posted: Published on October 28th, 2014

Since last year, Im sharing some trends in cell therapy clinical trials. Real time tracking of all registered trials allows to identify trends in multiple dimensions. Today Im posting a snapshot of trending for the last 3 years from 2011 to 2013. There could be some minimal discrepancies in numbers between this and previous reports (due to accidental detection of trials which were not captured initially). Please refer to this report as the latest update. Total number of trials Total number of cell therapy trials, registered in international databases, continue to increase. From 2011 to 2013 a total number of trials increase about 2 times. The value of US NCT database (ClinicalTrials.gov) remains constant over the years, representing 74% of all registered cell therapy trials internationally. Sponsorship The number on industry-sponsored clinical trials significantly increased in 2013, compared to previous two years. In the same time, the number of academic trials continue to grow even more rapidly. Demographics As in the previous 2 years, US and China dominated all other countries in number of cell therapy trials in 2013. However, the US trend is positive, but Chinas trend is negative. Interestingly, Japan made a biggest jump up in 2013. South … Continue reading

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Guidance for Human Somatic Cell Therapy and Gene Therapy – FDA

Posted: Published on October 28th, 2014

Definitions of Somatic Cell Therapy and Gene Therapy Recently, various innovative therapies involving the ex vivo manipulation and subsequent reintroduction of somatic cells into humans have been used or proposed. Somatic cell therapy is the administration to humans of autologous, allogeneic, or xenogeneic living cells which have been manipulated or processed ex vivo. Manufacture of products for somatic cell therapy involves the ex vivo propagation, expansion, selection (see: "A Proposed Approach to the Regulation of Cellular and Tissue-based Products", Feb. 28, 1997, (62 FR 9721)), or pharmacologic treatment of cells, or other alteration of their biological characteristics. Such cellular products might also be used for diagnostic or preventive purposes. Manufacturers should review policy and regulations to determine how a particular somatic cell therapy or gene therapy product is regulated. Recently, various innovative therapies involving the introduction of somatic cells into humans have been used or proposed. For the purpose of this Guidance, the term somatic cell therapy refers to the administration to humans of autologous, allogeneic, or xenogeneic living non-germline cells, other than transfusable blood products, for therapeutic, diagnostic, or preventive purposes. Gene therapy is a medical intervention based on modification of the genetic material of living cells. Cells may … Continue reading

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Stem Cell Therapy Help Buddy the Beagle – Video

Posted: Published on October 27th, 2014

Stem Cell Therapy Help Buddy the Beagle Buddy the beagle wasn't able to walk when he first arrived at the University of Minnesota Veterinary Medical Center. With the help of the Veterinary Medical ... By: UMN Health … Continue reading

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Plenary Session: Cell Therapy Product Development – Video

Posted: Published on October 27th, 2014

Plenary Session: Cell Therapy Product Development As more products head into later stage clinical development inevitably there will be successes and setbacks along the way. How do we educate key stakeholder ... By: Alliance for Regenerative Medicine … Continue reading

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Scleroderma patients seek experimental U.S. stem cell therapy

Posted: Published on October 27th, 2014

CTVNews.ca Staff Published Saturday, October 25, 2014 10:30PM EDT Last Updated Saturday, October 25, 2014 11:46PM EDT An estimated 16,000 Canadians live with scleroderma, an incurable autoimmune disorder which causes the body to produce too much collagen, resulting in a hardening of the skin and tissue. There is no cure for the scleroderma, but some patients in Canada are now seeking a costly and experimental stem cell therapy in the U.S. A little over a year ago, Mike Berry of Kingston, Ont., started having trouble breathing. It was the first sign of scleroderma. Berry, 42, suffers from the systemic version of scleroderma, which attacks his internal organs. His lungs have been scarred by the disorder, with his lung capacity dropping to 41 per cent in just nine months. His disease may ultimately be fatal. He described to CTV News how scleroderma has impacted his day-to-day life. "I'm unable to work any longer; it affects me and everything now," he said. "It's hard to walk fast; I can't walk and talk." Drugs to treat his scleroderma haven't worked, so now Berry is trying to fundraise more than $150,000 for an experimental U.S. stem cell treatment called Autologous Hematopoietic Stem Cell Transplantation … Continue reading

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LCT collaborates to develop novel neurological treatments

Posted: Published on October 27th, 2014

Living Cell Technologies collaborates to develop novel neurological treatments Living Cell Technologies Limited has formed a collaboration with the Centre for Brain Research (CBR). The research collaboration will identify additional neurodegenerative disease targets for clinical studies of LCTs lead product NTCELL. Directed by Professor Richard Faull, ONZM MBChB PhD DSc FRSNZ, University of Auckland Distinguished Professor, the CBR has a specialised interest in neurodegenerative diseases such as Parkinsons, Huntingtons, motor neurone and Alzheimers diseases. LCT has the expertise to identify and commercialise treatments and products from CBR research. Its therapeutic treatment NTCELL is currently in a Phase I/IIa clinical study targeting Parkinsons patients who have failed current symptomatic therapy. Professor Richard Faull said, The results of LCTs research studies are impressive and provide strong evidence that NTCELL has the potential to provide significant improvement in patients with Parkinsons disease. We believe this collaboration can help realise the potential of cell therapy for neurodegenerative diseases. Dr Ken Taylor, LCT chief executive said, The collaboration is in line with our focus to develop and market NTCELL therapy for Parkinsons patients failing current therapy while also investigating the potential of our patented cell therapy for other neurodegenerative disorders. Ends For further information: http://www.lctglobal.comContinue reading

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Plenary Session: Gene Therapy & Gene-Modified Cell Therapies – Video

Posted: Published on October 25th, 2014

Plenary Session: Gene Therapy Gene-Modified Cell Therapies This session will bring together several of the leading in-vivo and ex-vivo gene therapy companies in addition to pharma companies making a large bet in gene-modified cell therapy. While the... By: Alliance for Regenerative Medicine … Continue reading

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University Of Pennsylvania’s T-Cell Therapy Shows Promising Results

Posted: Published on October 22nd, 2014

By C. Rajan, contributing writer The University of Pennsylvania has announced promising results of its novel chimeric antigen receptor (CAR) therapy for cancer. In the study involving 25 children and five adults with end-stage acute lymphoblastic leukemia (ALL), there was an impressive 90 percent response rate with complete remission. Twenty-seven of the 30 patients went into complete remission after receiving the investigational therapy (called CTL019), and 78 percent of the patients were alive six months after treatment. The longest remission among the patients has lasted almost three years. The patients who participated in these trials had relapsed as many as four times, including 60 percent whose cancers came back even after stem cell transplants. Their cancers were so aggressive they had no treatment options left, said the studys senior author, Stephan Grupp, MD, PhD, at the Children's Hospital of Philadelphia. The durable responses we have observed with CTL019 therapy are unprecedented. The ongoing study is being conducted by researchers at the Childrens Hospital of Philadelphia and the Hospital of the University of Pennsylvania (Penn). The CAR trial program enrolling children with leukemia is also expanding to nine other pediatric centers. The experimental CAR therapy received FDAs breakthrough designation in July … Continue reading

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Shannon Layne, DVM and VCA Dunmore Animal Hospital Now Offer Stem Cell Therapy to Pet Patients in Pain

Posted: Published on October 18th, 2014

Dunmore, Pennsylvania (PRWEB) October 17, 2014 VCA Dunmore Animal Hospital is proud to announce the addition of Shannon Layne, DVM and her interest in stem cell therapy to their team. Credentialed in Regenerative Cell Therapy with Vet-Stem since January of 2011, Dr. Layne has proudly been treating pets with osteoarthritis and ligament injuries in north-east Pennsylvania with stem cell therapy for the last four years. Dr. Layne graduated from North Carolina State University, College of Veterinary Medicine in 2010 and has taken a special interest in Regenerative Veterinary Medicine and stem cell therapy since. In contrast to widely used drug therapies for pain management, cell-based therapies (like stem cell therapy) can promote healing, reduce inflammation, and decrease pain. Dr Layne also offers traditional Chinese veterinary medicine including acupuncture and Chinese herbs if clients are interested in a more holistic approach. Stem cells are regenerative cells that can differentiate into many tissue types (reducing pain and inflammation) thus helping to restore range of motion and regenerate tendon, ligament and joint tissues (Vet-Stem.com/science). In a study using Vet-Stem Regenerative Cell Therapy on dogs with osteoarthritis of the hip joint it was found that regenerative cell therapy (adipose-derived stem cells) decreases patient discomfort … Continue reading

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