Manufactured Stem Cells To Advance Clinical Research

Researchers supported by NIH have 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 such 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. Cells developed in this manner are called induced pluripotent stem cells. With NIH support, these cells were manufactured by Lonza, Walkersville, Md., and described in a publication by Dr. Behnam Baghbaderani and colleagues in Stem Cell Reports.

These clinical-grade stem cells are different from the more common laboratory-grade cells—those 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 Food and Drug Administration that ensures each batch of cells produced will meet quality and safety standards required for potential clinical use. 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 Dr. James M. Anderson, director of NIH’s 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.”