FDA Clears ISCO's Parthenogenetic Stem Cells For Investigational Clinical Use

By Cyndi Root

International Stem Cell Corporation is now approved to manufacture human parthenogenetic stem cells. The Food and Drug Administration (FDA) cleared the cells for investigational clinical use. The company announced the approval in a press release, stating that it improves its chance for approval of its Parkinsons disease treatment and provides an avenue for using the cells in other indications such as stroke or traumatic brain injury.

Dr. Ruslan Semechkin, ISCO's Chief Scientific Officer, said, "Many stem cell lines can never be used to develop commercial therapeutic products because they don't meet the FDA's ethical and quality standards. With this clearance from the FDA, the Company has removed any uncertainty in the potential clinical use of human parthenogenetic stem cells."

FDA Action

Like all manufacturing to FDA standards, stem cells must be produced in good manufacturing practice (GMP) conditions. The cells must be grown under repeatable conditions and be identical, so that patients receive standardized stem cell therapy. In addition, the federal agency seeks to reduce the risk of an infectious disease. ISCO provided the FDA assurances relating to the original egg donor's risk of infectious diseases, the testing of the master cell bank, and the genetic stability of the stem cell line. ISCO intends to produce the stem cells at its facility in Oceanside, CA and will provide an update on the first batch later.

Parthenogenetic Stem Cells

ISCO states that its parthenogenetic stem cells (hpSCs) are a new class of stem cells with the best characteristics of other stem cells. The company creates the cells by stimulating the donors oocytes (eggs), which are not fertilized and are not viable embryos. Stimulating the oocytes begins the process of cell division. This method creates cells that are histocompatiblethey do not depend on the target patient. Immunomatching and using unfertilized oocytes provides an ethical advantage and a reliable source for cell-based therapy.

Parkinson's Disease Submission

Dr. Semechkin stated the FDA manufacturing approval provides a boost to its Parkinson's disease submission, which the company intends to submit by the end of 2014. ISCO provided an update on the program in October 2014, stating that none of the preclinical pharmacology and toxicology studies have shown adverse events or pathological reactions. ISCO intends to present the results of those studies at the Society for Neuroscience annual meeting.

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FDA Clears ISCO's Parthenogenetic Stem Cells For Investigational Clinical Use