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1.5.8 Alliance for Harmonization of Cellular Therapy
Accreditation (AHCTA) and the Foundation
for the Accreditation of Cellular Therapy (FACT)
AHCTA and FACT both play an important role in developing harmonized standards
with regard to cellular therapy. AHCTA commits itself to the harmonization of
global standards with the aim of creating a single set of quality, safety, and profes-
sional requirements for cellular therapy, including hematopoietic stem cell (HSC)
transplantation, addressing all aspects of the process, from assessment of donor
eligibility to transplantation and clinical outcome. Represented by, among others,
the American Association of Blood Banks (AABB), American Society for Blood
and Marrow Transplantation (ASBMT), European Federation for Immunogenetics
(EFI), European Group for Blood and Marrow Transplantation (EBMT), Foundation
for the Accreditation of Cellular Therapy (FACT), International Society of Cellular
Therapy (ISCT) (Europe), Joint Accreditation Committee ISCT and EBMT
(JACIE), and the World Marrow Donor Association (WMDA), AHCTA released a
position paper in 2006, revised in 2008, entitled “Towards a Global Standard for
Donation, Procurement, Testing and Distribution of HSC and Related Cellular
Therapies” (AHCTA 2008 ).
FACT , a nonprofi t corporation cofounded in 1996 by the International Society
for Cellular Therapy (ISCT) and the American Society of Blood and Marrow
Transplantation (ASBMT) for the purposes of voluntary inspection and accredi-
tation in the fi eld of cellular therapy, focuses on developing standards for high-
quality medical and laboratory practice in cellular therapies. These standards are
developed by expert committees consisting of clinicians, scientists, technolo-
gists, and quality experts that cover the entire spectrum of cell manufacturing
(FACT 2015 ).
1.5.9 Future Global Regulation
The rapidly evolving fi elds of stem cell research and therapy require regulators and
policy makers to provide clear and unambiguous, yet fl exible rules and guidelines
which will ensure public safety on the one hand, yet not impede scientifi c innova-
tion. Clear and harmonized standards and guidelines will, in addition to some of the
benefi ts mentioned above, assist in curbing the proliferation of unsafe or potentially
harmful experimental treatments offered to vulnerable patients, which are generally
excluded from the scope of the regulation of medicines. However, with increasing
attention on the creation of a harmonized global framework for stem cell research
and therapy, care should be taken not to introduce too many uncoordinated harmo-
nization activities, which may introduce unintended obstacles that will need to be
navigated in an already uncertain terrain.
W.M. Botes et al.