FDA Approves First Blood Product for Stem Cell Therapy

Nov 23, 2011   

On November 10, 2011, the U.S. Food and Drug Administration (FDA) announced its approval of the first blood product derived from cord blood indicated for treatment as a stem cell therapy. HEMACORD, the hematopoietic progenitor cell-cord (HPC-C) blood product, is intended for use in HPC transplant procedures for individuals affected with various blood disorders.

FDA has recently begun requiring HPC-C manufacturers to submit license applications or investigational new drug applications in order to market these products. Having issued a guidance document detailing the regulatory requirements in 2009, FDA instituted a two-year phase-in period for HPC-C manufacturers. According to the FDA’s press release detailing the approval, found here, HEMACORD marks the first approval of a license application for cord blood as the Agency’s two-year phase-in period for HPC-C manufacturers comes to a close. The phase-in period ended on October 20, 2011.  While the regulatory environment surrounding HPCs and stem cells in general has proven cumbersome to manufacturers, with approvals being scarce since the regulations were promulgated in 2001, the approval may be the first of many in the coming years.

We question, however, whether this “product” approval will ultimately benefit anyone. Doctors have been treating their patients using cord blood for more than 20 years, and more than 20,000 patients have been successfully treated in that time. More information about the history of cord blood transplantation may be found here.

For more information about the FDA regulations or the FDA approval process, contact us at contact@fidjlaw.com.