StemCells Communicating With FDA on Proposed Phase I Trial

StemCells has been in communication with the FDA regarding the filing of the company's first investigational new drug (IND) application.

The filing is for a Phase I clinical trial of StemCells' proprietary neural cell therapy product -- HuCNS -- in Batten disease. The FDA has orally informed the company that it has suggestions and questions related to the proposed trial that require additional information from the company and has placed the proposed trial on hold.

Consistent with normal FDA procedures, the FDA is expected to formally communicate the precise nature of these issues in writing to StemCells within 30 days. In the interim, StemCells expects to be in active dialogue with the FDA to address the outstanding issues.

It is important to note that none of the FDA's suggestions or questions are related to contaminated embryonic stem cells that have been the matter of recent attention. StemCells does not use embryonic stem cells and does not use mouse feeder cells in any way in preparing its stem cells. All cells prepared by StemCells are grown in serum-free media and do not come into contact with cells from animals, the company said.