FDA Approves P1 Stem Cell Study Using Patient’s Own Bone Marrow for MS

A bone marrow harvest.

The FDA has approved a clinical trial to test a stem cell therapy to treat multiple sclerosis using the patient’s own bone marrow—the first of its kind, the Disc MS Research Center of New York. The FDA approved an IND from Disc for a PI trial to investigate a regenerative strategy using stem cells from the bone marrow.

Multiple sclerosis, affecting about 2.1 million people worldwide, is a chronic human autoimmune disease of the central nervous system that leads to damage to the insulating layer around the nerves, or the myelin. For the Disc study, stem cells will be injected into the cerebrospinal fluid surrounding the spinal cord in 20 participants.

“To my knowledge, this is the first FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment,”said Saud A. Sadiq, principal investigator of the clinical trial and a senior research scientist at the Disc MS Research Center.

  • This will be an open-label safety and tolerability study.
  • After participants undergo a bone marrow collection procedure, Sadiq and his team will derive the mesenchymal stem cell-derived neural progenitor cells (MSC-NPs), or cells from the immature embryonic connective tissue. These cells will be isolated, expanded, and tested prior to injection.
  • According to the Disc MS Research Center announcement, participants will receive three rounds of injections at three-month intervals, and safety and efficacy parameters will be evaluated in all participants through regular follow-up visits.
  • The research center hopes to begin the clinical trial as soon as possible, and anticipates being able to test the new treatment in the fall. The study still needs to undergo review and approval by the institutional review board, and the center is hoping to raise funds to move forward. <BNA>

The Bottom Line:  This study exemplifies the Disc MS Research Center’s dedication to translational research and provides a hope that established disability may be reversed in MS. FDA’s approval of the clinical trial is the culmination of a decade of stem cell research led by Sadiq and Violaine Harris, a research scientist at the Disc MS Research Center. In preclinical testing, Sadiq and Harris found that the injection of these cells may decrease brain inflammation, and promote myelin repair or neuroprotection, or both.

– See more at: http://www.scimitarequity.com/articles/fda-approves-p1-stem-cell-study-using-patients-own-bone-marrow-ms#sthash.Y9xxcSHj.dpuf

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