July 30, 2018 (Kyoto, Japan) – Kyoto University Hospital, in partnership with the Center for iPS Cell Research and Application (CiRA), Kyoto University, has planned physician-initiated clinical trials for Parkinson’s disease that transplants dopaminergic progenitors1 generated from induced pluripotent stem (iPS) cells. The clinical trial notification was submitted to the Pharmaceutical and Medical Devices Agency (PMDA; the Japanese equivalent of the FDA) on June 4, 2018, and the clinical trials are scheduled to begin on August 1 this year. [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…]
NurOwn® – BrainStorm Signs Dana-Farber as Second Manufacturing Site in U.S.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has contracted with the Cell Manipulation Core Facility at Dana-Farber Cancer Institute to manufacture NurOwn® for the company’s ongoing multi-dose Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). Dana-Farber will be the second U.S. manufacturing site to supply NurOwn for BrainStorm Cell Therapeutics’ ongoing trial. [Read more…]
Cynata Reports Positive 28-day Data from Cohort B of Phase 1 Trial of CYP-001 in GvHD
MELBOURNE, Australia, June 21, 2018 — Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce positive safety and efficacy data from a day 28 analysis of patients in Cohort B of its Phase 1 clinical trial of CYP-001, the Company’s lead Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD). [Read more…]
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