Evaluation of Multiple Intravenous Infusions of Autologous Adipose-Derived Mesenchymal Stem Cells in Parkinson's Disease: A Randomized, Double-Blind Clinical Trial.

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)

Introduction The purpose of this trial was to evaluate preliminary efficacy and safety of multiple intravenous infusions of autologous, Hope Biosciences adipose-derived mesenchymal stem cells (HB-adMSCs) for the treatment of patients with Parkinson's disease (PD). Methods A total of N = 24 patients with PD were randomized 5:3 into HB-adMSC (200 million) or Placebo. Six intravenous infusions of HB-adMSCs or saline were administered at Weeks 0, 4, 8, 16, 24, and 32 with a follow-up at Week 42 and the end of study (EOS) at Week 52. The primary efficacy endpoint was to investigate change from baseline to Week 52 in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. Primary safety endpoints included the incidence of adverse and serious adverse events (AE/SAEs) and clinically significant changes in laboratory assessments. Results HB-adMSC treatment was well tolerated and safe, with only one SAE reported, which was deemed unrelated to the investigational product. In total, 81 AEs were recorded, 79 of which were mild, one moderate, and one severe. Neurological disorders were the most commonly reported AEs, with a higher incidence in the placebo group (66.7%) compared with the HB-adMSC group (46.7%). No deaths occurred, and no clinically meaningful changes were observed in laboratory parameters from baseline to the EOS for either group. Efficacy anal

Evidence level

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

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