A study published in the journal Multiple Sclerosis and Related Disorders, led by researchers at Mount Sinai in New York and Celgene Cellular Therapeutics revealed that an infusion based on cells derived from the placenta proved to be safe for patients withmultiple sclerosis (MS) and a promising new therapy for the disease. The study is entitled “Human placenta-derived cells (PDA-001) for the treatment of adults with multiple sclerosis: A randomized, placebo-controlled, multiple-dose study.”
MS is a progressive neurodegenerative autoimmune disorder that results from an attack on the central nervous system (CNS) by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects nerve fibers in the CNS. Myelin loss leads to impairment in signal transmission along the nerve fibers, affecting motor function (such as coordination, balance, speech and vision), causing irreversible neurological disability, paralysis and blindness. MS usually starts as an episodic disorder known as relapsing-remitting MS (RRMS), and in many patients it evolves into a more severe chronic condition with worsening disability named secondary progressive MS (SPMS). It is estimated that more than 2.3 million people in the world suffer from the disease.
It has been previously shown that therapeutic cell-based infusions have an immunomodulatory and repair action in MS. PDA-001 in particular is a preparation of cultured mesenchymal-like cells derived from healthy human placental tissue and designed for the treatment of MS as these cells have immunomodulatory, anti-inflammatory, pro-regenerative and neuroprotective properties. As these placenta cells are expanded in cell culture, one healthy donor is capable of supplying enough cells for several patients.
In the study, researchers tested the safety and possible exacerbation of the disease with this new MS treatment approach based on PDA-001. A phase 1b, randomized, multicenter, double-blind, placebo-controlled study was conducted with 16 MS patients (10 with RRMS and 6 with SPMS), aged between 18 and 65 years. Six patients received a high dose of PDA-001 (600×106 cells), other six were given a lower dose (150×106 cells), and the remaining four patients received a placebo. Patients were monthly monitored for brain lesions through brain magnetic resonance imaging scans to assess possible disease progression.
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