Cultured meat refers to lab-grown meat created using cell culture techniques. It is produced by growing master cells collected from cattle, chicken, pigs, fish, and lamb, as well as other types of livestock and seafood. In addition to meat and seafood production, cultured meat techniques can be used to ethically manufacture other types of animal products, such as leather, fur, milk, and hen-free egg whites, for example. Cultured meat is ethically produced, because livestock is not used within the manufacturing processes beyond collecting the initial cells for culture. [Read more…]
Diversifying Cord Blood Banking through Adipose-Derived Stem Cell Storage
The global cord blood banking industry has been rapidly maturing in recent years. In part, this has been caused by changes in processing, storage, and transplantation technologies. These changes require executives and industry decision-makers to have a firm understanding of emerging trends.
One of the most notable cord blood industry trends has been a diversification of services. Put simply, cord blood banks are becoming diversified stem cell biobanks. [Read more…]
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using MSCs a Prophylactic Against COVID-19
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…]
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…]
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