New standards for umbilical cord cells proposed

WASHINGTON (Reuters) - U.S. health officials proposed new standards on Tuesday meant to help companies and other organizations seek approval to sell stem cells from newborn's umbilical cord blood used to treat some cancers and other diseases.

The Food and Drug Administration said it would allow cord blood banks that store the cells to submit research already available on use of the cells in an effort to streamline the approval process, rather than require them to conduct their own clinical trials.

Like companies selling other products, the banks must also meet other handling, storing and packaging requirements to win approval for the cells, the agency said.

Ellen Lazarus, an FDA medical officer in the division of human tissue, said use of the cells went so rapidly from research use to clinical use that the agency "didn't want to get in the way of development of the necessary medical technology," but did want to set clear guidelines for a bank to be approved.

Umbilical cord blood contains stem cells that can be used to treat bone marrow failure, immune system deficiencies and some cancers such as leukemia among other conditions in both children and adults. Researchers are also studying their use for other diseases, such as Alzheimer's and Parkinson's.

A mix of for-profit and not-for-profit companies collect cord blood donations for research and public use. Some companies offer private storage, including Celgene Corp.'s Lifebank USA and Viacell Inc.'s Viacord, although they may also sell some cells for public use.

Both public and private banks already must meet FDA requirements for handling human cells, including facility inspections.

Mandatory approval for public banks would go into effect as soon as the standards are finalized following a 90-day comment period, the FDA said. Stephanie Simek, deputy director of the FDA's Office of Cellular, Tissue and Gene Therapies, said she hoped that could be completed within months.

Companies could apply for approval before the final guidelines are issued, Simek added.

The new standards would not apply to banks that manage cord cells for private use when parents pay to store their children's cells for possible future therapy. Those firms do not need licenses because they do not make cells widely available, an FDA spokeswoman said.