The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...

A major milestone in stem cell therapy was reached in December 2014 when a European Medicines Agency (EMA) committee recommended the conditional approval of Holoclar, the first stem-cell product to be recommended for approval in the EU. Background Holocloar, developed by Chiesi Farmaceutici S.p.A. and Holostem Terapie Avanzate, is an advanced-therapy medicinal product (ATMP) granted orphan designation for limbal stem cell deficiency (LSCD) caused by chemical or physic...

As anyone working in the healthcare products sector can attest to, definitions are vitally important in the regulation of products. Definitions are the difference between a manufactured pharmaceutical product being overseen by US Food and Drug Administration (FDA) regulators and a compounded pharmaceutical product being overseen by state boards of pharmacy; the difference between an in vitro diagnostic test regulated by FDA and a lab-developed test by the Clinical Labor...

India's Ministry of Health and Welfare (MOHW) issued an order on 3 June 2013 establishing a High Powered Committee to advise it on the regulation of stem cell products and other cell based therapies. The Committee will consist of four members, including a representative from the stem cell industry, and must submit a report with its recommendations to the Ministry within two months.  The terms of reference for the Committee include: Reviewing the current status o...

China's Ministry of Health and the State Food and Drug Administration (SFDA) have proposed draft regulations governing stem cell clinical trial management and the quality control of stem cell preparations and pre-clinical research. All proposed clinical trials on stem cells would be subject to prior review by ethics committees, and sponsors would be required to submit informed consent forms, safety evaluation and research protocols as well as information concerning th...

Stem cell-based therapies are arriving in the clinic as Phase 1 studies. Which technological challenges and US Food and Drug Administration (FDA) regulations govern the development and translation of stem cell therapies into medical treatments? Irving Weissman, MD, PhD, discussed the current and future caveats of bringing stem cell therapies to clinical trials at the Institute of Stem Cell Biology and Regenerative (ISSCR) conference in San Francisco on 15 June 2010. "W...

The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...

Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from-and later put back into-a person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier , head of FDA practice at the law firm Sidley Austin LLP, argues FDA's efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent an...

The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products-an opening salvo in what is likely to be a lengthy court battle between the agency and a company accused of violating federal regulations. The entire case results from a 2008 enforcement activity by FDA in which it found Colorado-based Regenerative Sciences to be in violation of federal law. In a 2008 warning let...

Canadian regulators have approved the world's first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics' Prochymal approval for the treatment of graft-versus-host disease (GVHD). GVHD affects patients who have undergone a bone marrow transplant, and results in the transplanted cells attacking the host's own cells. Osiris' Prochymal uses stem cells extracted from the bone marrow of adults, side-stepping ethical issues inherent in...

The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...

The state of Texas approved new-and controversial-rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Times . The changes, instituted 13 April by the Texas Medical Board, were reportedly spearheaded by Texas Governor and former Republican presidential nominee Rick Perry, who has said he experienced relief from the procedures, reports The Times . Some researchers, however, are ...