US, June 24, 2016 – Research funded by the National Institutes of Health(NIH) had developed a clinical-grade stem cell line, which has the potential to accelerate the advance of new medical applications and cell-based therapies for millions of people suffering from ailments as Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.
The stem cells were developed by isolating human umbilical cord blood cells following a healthy birth, and coaxing them back into a pluripotent state, or one in which they have the potential to develop into any cell type in the body, the NIH said.
According to NIH, cells developed in this manner are called induced pluripotent stem cells (iPSCs).
With NIH support, these cells were manufactured by Lonza, Walkersville, Maryland, and described in a publication by Behnam Baghbaderani, Ph.D., and colleagues in Stem Cell Reports.
“Providing access to clinical-grade stem cells removes a significant barrier in the development of cell-based therapies”, says James M. Anderson, M.D., Ph.D., Director, Division of Program Coordination, Planning, and Strategic Initiatives.
According to NIH, these clinical-grade stem cells are different from the more common laboratory-grade cells used in most scientific publications, because unlike laboratory-grade stem cells, clinical-grade stem cells can be used for clinical applications in humans.
“ The distinctive feature of this cell line is that it was developed under current good manufacturing practices (cGMP), a set of stringent regulations enforced by the U.S. Food and Drug Administration which ensures each batch of cells produced will meet quality and safety standards required for potential clinical use’’, the NIH said.
The NIH Common Fund’s Regenerative Medicine program supported the manufacturing of this cell line.
“The Common Fund aims to accelerate research progress by developing new tools and resources for the biomedical research community through strategic investments in high-impact research,” said James M. Anderson, M.D., Ph.D., director of the NIH Division of Program Coordination, Planning, and Strategic Initiatives, which houses the Common Fund.
“Since meeting cGMP guidelines is very time-intensive and costly, providing access to clinical-grade stem cells removes a significant barrier in the development of cell-based therapies, ” NIH added.
The researchers used mice and reported that significant progress with stem cell therapy in mice is already underway.
“Researchers have reversed diabetic conditions in mice using iPSC-generated insulin-producing cells and have partially restored limb function in mice with spinal cord injuries. Translating these studies into humans is the next challenge, and by making clinical-grade stem cells available, NIH hopes to speed up the development of new stem cell therapies for patients’’, NIH said.
. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
