NeoStem's Subsidiary, Progenitor Cell Therapy (PCT), Awarded FACT Re-Accreditation for New Jersey and California Facilities
May 15 2014 - 7:30AM
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."
About PCT
Progenitor Cell Therapy (PCT), a wholly owned subsidiary of
NeoStem, Inc., is a leading contract development and manufacturing
organization in the cellular therapy industry. For over 15 years,
PCT has provided pre-clinical and clinical cGMP development and
manufacturing services to more than 100 clients, advancing
regenerative medicine product candidates from the development stage
all the way through to human testing. PCT has two cGMP-compliant,
state-of-the art facilities in New Jersey and California to serve
the cell therapy industry and offers manufacturing of cell
therapy-based products, engineering and innovation services,
process and product development, cell and tissue processing,
collection and storage, regulatory consulting, facility design,
validation, and due diligence evaluations.
www.pctcelltherapy.com
About NeoStem, Inc.
NeoStem is a leader in the emerging cellular therapy industry,
pursuing the preservation and enhancement of human health globally
through the development of cell based therapeutics that prevent,
treat or cure disease by repairing and replacing damaged or aged
tissue, cells and organs and restoring their normal function. The
business includes the development of novel proprietary cell therapy
products as well as a revenue-generating contract development and
manufacturing service business. This combination has created an
organization with unique capabilities for cost effective in-house
product development and immediate revenue and cash flow generation.
www.neostem.com
About FACT
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.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements reflect management's current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. Forward-looking statements include
statements herein with respect to the successful execution of the
Company's business strategy, including with respect to the
Company's ability to develop and grow its business, the successful
development of cellular therapies with respect to the Company's
research and development and clinical evaluation efforts in
connection with the Company's Targeted Immunotherapy Program, CD34
Cell Program and T Regulatory Cell Program and other cell
therapies, the future of the regenerative medicine industry and the
role of stem cells and cellular therapy in that industry and the
performance and planned expansion of the Company's contract
development and manufacturing business. The Company's actual
results could differ materially from those anticipated in these
forward-looking statements as a result of various factors. Factors
that could cause future results to materially differ from the
recent results or those projected in forward-looking statements
include the "Risk Factors" described in the Company's Annual Report
on Form 10-K filed with the Securities and Exchange Commission
("SEC") on March 13, 2014, the Company's Current Report on Form 8-K
filed with the SEC on May 8, 2014 and in the Company's other
periodic filings with the SEC. The Company's further development is
highly dependent on future medical and research developments and
market acceptance, which is outside its control.
CONTACT: Investor Contact:
LifeSci Advisors, LLC
Michael Rice
Founding Partner
Phone: +1-646-597-6979
Email: mrice@lifesciadvisors.com
Media Contact:
NeoStem, Inc.
Eric Powers
Manager of Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@neostem.com
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