Safety and feasibility of intravenous fresh adipose-derived mesenchymal stem cells in secondary progressive multiple sclerosis: phase I/IIa clinical results.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Objective Mesenchymal stem cells (MSCs) hold substantial promise in regenerative medicine owing to their immunomodulatory, neuroregenerative, and self-renewal properties. Adipose tissue (AT) serves as an optimal MSC source due to its high yield and rapid proliferation. This study evaluated the safety and exploratory clinical effects of non-cryopreserved, culture-expanded autologous AT-MSCs in patients with secondary progressive multiple sclerosis (SPMS). Methods High-dose fresh autologous AT-MSCs (4.4 × 10 6 ± 1.7 × 10 6 cells) were intravenously administered to 10 female patients with SPMS (Expanded Disability Status Scale [EDSS] score 4-6) in two doses, seven days apart. Adverse events were monitored for 9 months post-transplantation. Magnetic resonance imaging (MRI) assessments quantified lesion number, volume, and contrast-enhancing lesions. EDSS scores, depression, and quality-of-life measures were evaluated over 9 months. MSC immunomodulatory effects were assessed via gene expression of inflammatory and anti-inflammatory cytokines and peripheral blood regulatory T-cell (Treg) proportions. Results No serious adverse events occurred over 9 months. AT-MSC therapy reduced T2-FLAIR lesion number and volume, improved EDSS scores, and enhanced psychological outcomes. It also increased Treg cell proportions and anti-inflammatory cytokine expression while decreasing inflammatory c

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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