Objective: To assess the impact of intravenous (IV) allogeneic bone marrow-derived mesenchymal stem cell (allo-hMSC) infusions on the quality of life (QoL) of patients with Parkinson’s disease (PwPD).

Background: Neuroinflammation plays a critical role  in the pathogenesis and progression of Parkinson’s disease (PD)[1]. allo-hMSC have been proposed as a potential disease-modifying therapy due to their anti-inflammatory and immunomodulatory properties [2]. However, the effect  of allo-hMSC on quality of life (QoL) remains unclear.

Method: Our investigator-initiated, double-blind, randomized, placebo-controlled phase 2 trial was conducted between November 2020 and July 2023 at a single academic center in the USA. Participants included men and women aged 50–79 years with mild-to-moderate PD (Hoehn & Yahr stages 1–3, disease duration of 2–10 years). They were randomized into one of three groups: (1) three IV infusions of 10×10⁶ allo-hMSCs/kg (N=16), (2) an IV placebo infusion followed by two IV infusions of 10×10⁶ allo-hMSCs/kg (N=14), or (3) three IV placebo infusions (N=15). Infusions were administered at 18-week intervals, with follow-up conducted at week 88. Secondary outcomes included QoL assessments using the Parkinson’s Disease Questionnaire (PDQ-39), and the EuroQol (EQ)-5D-5L Index Score at baseline and 88 weeks. Bayesian statistical analysis determined the posterior probability of change from baseline between treatment arms. Data were analyzed using R v.4.2.0.

Results: 45 participants PwPD were enrolled, and 40 completed week 88 follow-up (figure1). Demographic and clinical characteristics were similar between groups at baseline (table1). The decrease in PDQ-39 scores was greater in the two-infusion allo-hMSC arm (Mean Difference [MD]: -7.7, Credible Interval [CrI]: -18.8 to 3.7, Posterior Probability [PP]: 90.9%) and the three-infusion allo-hMSC arm (MD: -4.94, CrI: -17.4 to 7.77, PP: 78.1%) (figure2A). Similarly, the EQ-5D-5L Index Score showed a greater increase in the three-infusion allo-hMSC arm (MD: 0.07, CrI: -0.03 to 0.17, PP: 90.0%) and the two-infusion allo-hMSC arm (MD: 0.08, CrI: -0.02 to 0.19, PP: 93.6%)(figure2B).

Conclusion: In our phase 2 clinical trial, IV allo-hMSC therapy demonstrated a potential benefit in improving QoL in mild-to-moderate PwPD. Further studies with larger cohorts are warranted to confirm these results and explore long-term effects.

Figure 1

Table 1

Figure 2

References: 1] Nesci S, Spagnoletta A, Oppedisano F. Inflammation, Mitochondria and Natural Compounds Together in the Circle of Trust. Int J Mol Sci. 2023 Mar 24;24(7):6106.
[2] Park HJ, Shin JY, Kim HN, Oh SH, Lee PH. Neuroprotective effects of mesenchymal stem cells through autophagy modulation in a parkinsonian model. Neurobiol Aging. 2014;35(8):1920–8.

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-allogeneic-bone-marrow-derived-mesenchymal-stem-cell-therapy-on-quality-of-life-in-patients-with-parkinsons-disease/