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…]
Nohla Therapeutics Receives FDA Fast Track Designation for Dilanubicel for Allogeneic Cord Blood Transplant Patients
SEATTLE, Aug. 06, 2018 — Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant. Dilanubicel has already received PRIME designation from the European Medicines Agency, and Orphan Drug Designation from the FDA and European Commission. [Read more…]
Cymerus™ MSC treatment leads to improved recovery of cardiac function in preclinical heart attack study
Melbourne, Australia; 31 July 2018: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), is pleased to announce positive efficacy data from a study of its Cymerus mesenchymal stem cells (MSCs) in a preclinical heart attack model. [Read more…]
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