New York, NY, May 15, 2014 — NeoStem, Inc. (NASDAQ:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC (“PCT”), announced today that PCT has been awarded re-accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). By demonstrating compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, PCT has earned FACT Accreditation for its Allendale, New Jersey and Mountain View, California sites. PCT’s accreditation is effective for three years beginning October 19, 2013.
“We are proud, once again, to obtain accreditation by FACT. We understand that our clients put a great deal of trust in PCT to deliver high quality products and consistent results, and the FACT accreditation is just one of the many ways that we demonstrate that our programs consistently meet or exceed industry standards for the use of cellular products,” said Dr. Robert Preti, Chief Scientific Officer of NeoStem and PCT and President of PCT.
FACT is an internationally-recognized accrediting body for hospitals and medical institutions offering stem cell transplant, and indicates the accredited institution has met the most rigorous standards in every aspect of stem cell therapy. This covers the entire spectrum of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release. FACT-JACIE Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy transplantation.
“FACT accreditation and the certification of other leading regulatory bodies demonstrate that PCT is meeting the highest standards of quality for stem cell therapy,” says Dr. Robin Smith, Chairman and CEO of NeoStem. “With more than 15 years of expertise in helping clients achieve their manufacturing and development goals, PCT has set a high bar for the cellular therapy industry.”
In December 1994, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT) merged their Standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation). The two societies established FACT in order to develop a voluntary Inspection and Accreditation Program based on the joint Standards. FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
In 2006, FACT, in collaboration with the Joint Accreditation Committee–ISCT & EBMT (JACIE), developed international standards in the field of cellular therapy. JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organizations involved with cellular transplantation in Europe.
Since 2007, FACT accreditation has been used in determining the U.S. News & World Report rankings of transplant centers for the “America’s Best Hospitals” and “America’s Best Children’s Hospitals” list.
The FACT Inspection and Accreditation Program was developed by Dr. Phyllis Warkentin, Chief Medical Officer of FACT, the FACT Board of Directors, as well as the ISCT and ASBMT Regulatory and Standards Committees. The first edition of the FACT Standards was published in September 1996, and the first inspections began in September of 1997 resulting in the first program being awarded accreditation in 1998.