Objective: To evaluate the impact of intravenous (IV) allogeneic bone marrow-derived mesenchymal stem cell (allo-hMSC) treatment on motor complications in Parkinson’s disease (PD).

Background: Motor complications, including motor fluctuations and dyskinesias, are common consequences of chronic symptomatic treatment in PD[1]. Although several pharmacological and surgical options exist, allo-hMSC therapy remains unexplored as a potential therapeutic approach for their management.

Method: In this randomized, double-blind, placebo-controlled Phase 2 trial[3], we enrolled individuals aged 50-79 with mild-to-moderate PD (Hoehn & Yahr stages 1-3, disease duration 2-10 years). Participants were assigned to one of three groups: (1) three IV infusions of 10×10⁶ allo-hMSCs/kg (N=16), (2) one IV placebo followed by two IV infusions of 10×10⁶ allo-hMSCs/kg (N=14), or (3) three IV placebo infusions (N=15). Infusions were spaced 18 weeks apart. Motor complications were assessed using the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part IV in the OFF-medicine state at baseline and 88 weeks. Levodopa Equivalent Daily Dose (LEDD) calculations[4,5] were performed at both time points. Bayesian analysis compared mean differences in MDS-UPDRS-IV and the percentage of subjects with a clinically significant adjustment (≥25% decrease in LEDD) between active treatments and placebo. Data were analyzed using R v.4.2.0.

Results: 45 participants were enrolled, with 40 completing follow-up at week 88 [figure1]. The placebo group had a lower baseline LEDD, while MDS-UPDRS-IV scores were similar across groups at baseline [table1]. In the three allo-hMSC infusion group, significant improvement in motor fluctuations was observed (MDS-UPDRS-IV Mean Difference = -0.7, Credible Interval: -2.7 to 1.3, Posterior Probability = 76.7%, [figure2a]) compared to placebo, with 94.7% of participants maintaining a stable LEDD throughout the study, compared to 66.5% in the placebo group [figure2b]. The two allo-hMSC infusion group showed a mild increase in MDS-UPDRS-IV [figure2a], with no significant change in LEDD [figure2b].

Conclusion: Three repeated infusions of allo-hMSCs resulted in a reduction of motor fluctuations and dyskinesias, which was not attributed to adjustments in levodopa medication. Larger clinical trials are needed to confirm the efficacy of allo-hMSCs in managing motor complications of PD.

Table 1

Figure 1

Figure 2

References: [1] Gandhi SE, Zerenner T, Nodehi A, Lawton MA, Marshall V, Al-Hajraf F, Grosset KA, Morris HR, Hu MT, Ben-Shlomo Y, Grosset DG. Motor Complications in Parkinson’s Disease: Results from 3343 Patients Followed for up to 12 Years. Mov Disord Clin Pract. 2024 Jun;11(6):686-697. doi: 10.1002/mdc3.14044. Epub 2024 Apr 8. PMID: 38587023; PMCID: PMC11145112.
[2] Aradi SD, Hauser RA. Medical Management and Prevention of Motor Complications in Parkinson’s Disease. Neurotherapeutics. 2020 Oct;17(4):1339-1365. doi: 10.1007/s13311-020-00889-4. PMID: 32761324; PMCID: PMC7851275
[3] ClinicalTrials.gov. Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson’s Disea [Internet]. Bethesda (MD): National Library of Medicine (US); 2023 [cited 2025 Feb 26]. Available from: https://clinicaltrials.gov/study/NCT02611167
[4] Levodopa Equivalent Dose Calculator [Internet]. Parkinson’s Measurement. [cited 2025 Feb 27]. Available from: https://www.parkinsonsmeasurement.org/toolBox/levodopaEquivalentDose.htm
[5] Jost ST, Kaldenbach MA, Antonini A, Martinez-Martin P, Timmermann L, Odin P, et al. Levodopa Dose Equivalency in Parkinson’s Disease: Updated Systematic Review and Proposals. Mov Disord. 2023 Jul;38(7):1236-1252. doi: 10.1002/mds.29410. Epub 2023 May 5. PMID: 37147135.

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