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 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…]
Be in the know about leading stem cell centers you can trust in this article. [Read more…]
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…]
“Stem Cell Research Products – Opportunities, Tools, & Technologies” is a global strategic report that evaluates opportunities across the entire stem cell product spectrum with an emphasis on opportunities for research product development.
Stem Cells Size | A Stem Cell Business Opportunity
In this article:
- About The Global Strategic Report
- Broad Categories Of Stem Cells
- Stem Cell Research and Its Commercial Interest
- Areas of Stem Cell Research
- Big Companies in Stem Cell Research Products and Key Report Findings