SAN CARLOS, Calif., Aug. 22, 2018 — In a Viewpoint paper published online today in Circulation Research, the Phase III CardiAMP Heart Failure Trial (CardiAMP-HF Trial) studying the investigational CardiAMP stem cell therapy from BioCardia®, Inc. (OTC: BCDA) was highlighted as an example of personalized medicine, with promising results from the first 10 patients in the roll-in cohort reported. The company believes this to be the first outcomes data published from any pivotal trial of a stem cell therapy for heart failure. The paper is authored by Peter Johnston, M.D., Eric Duckers, M.D., Ph.D., Amish Raval, M.D., Thomas Cook, Ph.D. and Carl Pepine, M.D. [Read more…]
Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia in Japan
San Diego, CA, USA, August 1st, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the Clinical Trial Notification (“CTN”), submitted by their Japan partner; ReproCELL, to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for a Stemchymal® SCA Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) has been approved. This is another key milestone for Steminent’s international Stemchymal® SCA Phase II clinical development program with trials now moving ahead in Taiwan, US, and Japan. [Read more…]
Parkinson’s Disease Clinical Trial to Launch in Japan | iPS Cell Trial
Japan will continue its dominance with iPS cell clinical trials with the launch of a physician-lead trial for Parkinson’s disease. In its July 2018 press announcement, Kyoto University announced that its University Hospital and the Center for iPS Cell Research and Application (CiRA) will launch the world’s first clinical trial for Parkinson’s disease to utilize an induced pluripotent stem cell (iPS cell) derived therapeutic product.
Existing iPS Cell Trials
This newest iPS cell trial represents only the third iPS cell trial to be undertaken worldwide. The other existing iPS cell trials are being conducted by the RIKEN Center for Developmental Biology (CDC) and Cynata Therapeutics (ASX:CYP), respectively. [Read more…]
Steminent Announces FDA Approval of IND for Phase II Clinical Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia
San Diego, CA, USA, July 18th, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to initiate its Phase II clinical trial for polyglutamine spinocerebellar ataxia (“PolyQ SCA”) to enroll patients at clinical sites in the United States. This is a key milestone for the Company’s international Stemchymal® SCA Phase II clinical trials program. [Read more…]
Dr. Paul Wotton on the Future of Cynata Therapeutics’ Novel iPSC-Derived MSCs
This is an interview with Dr. Paul Wotton, who joined Cynata Therapeutics Board of Directors in June, 2016. Dr. Wotton was previously President and CEO of Ocata Therapeutics, Inc. (NASDAQ: OCAT) joining the company in July 2014 and managing it through an all-cash take-over by Astellas Pharma valued at $379 million. [Read more…]
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