June 26, 2020, HOUSTON — Celltex, a Houston, Texas-based biotechnology company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19). [Read more…]
Stem Cell Research Products | Market Size, Segments, & Trends
“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.
This report explores market opportunities by stem cell type, including MSCs, hematopoietic stem cells, induced pluripotent stem cells, embryonic stem cells, neural stem cells, and other stem cell types.
In this article:
Top 5 TED Talks About Stem Cells
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…]
