Patients with multiple sclerosis (MS) were able to safely tolerate treatment with cells cultured from human placental tissue, according to an article (“Human placenta-derived cells (PDA-001) for the treatment of adults with multiple sclerosis: A randomized, placebo-controlled, multiple-dose study”) published in Multiple Sclerosis and Related Disorders. The study, which is the first of its kind, was conducted by researchers at Mount Sinai, Celgene Cellular Therapeutics, and collaborators at several other institutions.

While designed to determine safety of the treatment, early signals in the data also suggested that a preparation of cultured PDA-001 cells may repair damaged nerve tissues in patients with MS. PDA-001 cells resemble mesenchymal stromal stem cells found in many tissues of the body. Since the cells are expanded in cell cultures, one donor is able to supply enough cells for many patients.

“This is the first time placenta-derived cells have been tested as a possible therapy for multiple sclerosis,” said Fred Lublin, M.D., director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, professor of neurology at the Icahn School of Medicine at Mount Sinai, and the lead investigator of the study. “The next step will be to study larger numbers of MS patients to assess efficacy of the cells, but we could be looking at a new frontier in treatment for the disease.”

The new safety study was conducted on 16 MS patients (10 with relapsing-remitting MS and six with secondary progressive MS) between the ages of 18 and 65. Six patients were given a high dose of PDA-001, another six were given a lower dose, and four patients were given placebo. Any time the immune system is altered, say by an experimental treatment, there is always a risk for MS to worsen, noted Dr. Lublin.

All subjects were given monthly brain scans over a six-month period to ensure they did not acquire any new or enlarging brain lesions, which would indicate a worsening of MS activity. No subjects showed any paradoxical worsening on MRI and, after one year, the majority had stable or improved levels of disability.

“PDA-001 infusions were safe and well tolerated in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis patients,” wrote the investigators. “No paradoxical worsening of lesion counts was noted with either dose.”

“We're hoping to learn more about how placental stromal cells contribute to myelin repair,” said Dr. Lublin. “We suspect they either convert to a myelin making cell, or they enhance the environment of the area where the damage is to allow for natural repair. Our long-term goal is to develop strategies to facilitate repair of the damaged nervous system.”

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