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

Source:   PLoS ONE 2018 . 13 ( 5 ) : e0195891 . doi: 10.1371/journal.pone.0195891 . 2018 05 16
PMID: 29768414
DOI: 10.1371/journal.pone.0195891

ABSTRACT

BACKGROUND

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

PATIENTS AND METHODS

In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded.

RESULTS

Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy.

CONCLUSION

Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

Author information
  1. Unidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
  2. Servicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  3. CABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
  4. Public Health Department, University of Malaga, Malaga, SPAIN.
  5. Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain.
  6. Servicio de Radiodiagnóstico, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
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