Adipose-derived mesenchymal stem cells (AdMSCs) for the treatment of secondary progressive multiple sclerosis: A triple-blind, placebo-controlled, randomized phase I/II safety and feasibility study

Currently available treatments for secondary progressive multiple sclerosis (SPMS) have limited efficacy. Adipose-mesenchymal-derived stem cells (AdMSCs) represent a promising option and can be easily obtained with minimally invasive procedures.

In this placebo-controlled study, stem cell samples were harvested from consenting patients via lipectomy and subsequently expanded. Patients were given a single placebo, low-dose (1×106 cells/kg) or high-dose (4×106 cells/kg) infusion of autologous AdMSC product, and these patients were then monitored and followed for 12 months thereafter.

Thirty-four patients underwent lipectomy for collection of AdMSCs. They were then randomized and 30 were infused (11 with placebo, 10 with low dose, and 9 with high dose); 4 patients did not receive the infusion because of karyotype abnormalities in the cell product.

Only one contraindication emerged after infusion: urinary infection, considered, however, to be unrelated to the study at hand. No other “safety” parameters showed changes.

The study showed, therefore, that the infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies in terms of number of participants and probably treatment at earlier stages of the disease would be needed to investigate the potential therapeutic benefit of this technique.