Check out the best TED Talks below to understand the growing importance of stem cells within regenerative medicine.
In this article:
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…]
Should Stem Cells Be Regulated As Drugs?
Should stem cells be regulated by the U.S. Food and Drug Administration (FDA) as drugs? This is a complex question and one that the FDA has continued to refine over the past several years.
FDA Regulation of Stem Cells
In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER). [Read more…]
Future of Regenerative Medicine with Kyle Cetrulo of AuxoCell
I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
Okyanos – Adipose-Derived Stem Cell Treatments with CEO Matt Feshbach
Founded in 2011, Okyanos (pronounced “Oh – key – AH – nos”) is an innovative stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic conditions. The literary name Okyanos, the Greek God of the river Okyanos, symbolizes the restoration of blood flow. Okyanos Cell Therapy delivers a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) using internationally-approved technology to patients with chronic, degenerative conditions. Okyanos is fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. [Read more…]
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