Movement disorders : official journal of the Movement Disorder SocietySep 2, 2025

Using Donor Stem Cells from Bone Marrow to Treat Parkinson's Disease: A Randomized Trial

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Updated Jan 6, 2026

Abstract

A larger proportion of patients achieved a ≥5-point improvement in motor function with three infusions of allo-hMSCs compared to placebo (93.7% probability).

The mean improvement in motor function for the three-infusion group was 16.9 points on the scale, while the placebo group improved by 14.6 points.
Fewer patients in the two-infusion group showed significant improvement compared to placebo, with a mean improvement of only 3.9 points.
All treatment arms exhibited some level of improvement in motor function on the MDS-UPDRS-III scale.
Adverse events reported were mild and transient, indicating a favorable safety profile for the allo-hMSC infusions.
Future studies are needed to explore the variability in clinical efficacy related to different batches of allo-hMSCs.

Simplified

BACKGROUND: Neuroinflammation contributes to Parkinson's disease (PD) progression and motor dysfunction. Allogeneic human mesenchymal stem cells (allo-hMSCs) may reduce neuroinflammation and improve motor symptoms.

OBJECTIVES: To evaluate the efficacy of repeated intravenous doses of 10 × 10/kg allo-hMSCs in improving motor symptoms in patients with PD (PwP). 6

METHODS: In this phase 2, randomized, placebo-controlled trial (November 2020-July 2023), mild-to-moderate PwP received either three allo-hMSC infusions, one placebo followed by two allo-hMSC infusions, or three placebo infusions at 18-week intervals. Follow-up lasted 88 weeks. The primary outcome was a >70% posterior probability (PP) of a difference in the proportion of participants with ≥5-point improvement in OFF-medication Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale-Part III () at week 62. Bayesian analysis was conducted using R v4.2.0.

RESULTS: Forty-five PwP were enrolled. A larger proportion of subjects achieved a ≥5-point improvement in MDS-UPDRS-III in the three-infusion arm compared with placebo at week 62 (mean difference [MD]: 5.0%, PP = 93.7%), translating to a 16.9-point improvement in MDS-UPDRS-III in the three-infusion arm compared with a 14.6-point improvement in the placebo arm. Conversely, fewer subjects in the two-infusion arm compared with placebo showed ≥5-point improvement at week 62 (MD: -62.4%, PP ≥ 99.9%), translating to only a 3.9-point improvement in MDS-UPDRS-III in the two-infusion arm. However, improvement in MDS-UPDRS-III was seen across all treatment arms. Adverse events were mild and transient.

CONCLUSIONS: Three infusions of 10 × 10allo-hMSCs/kg improved motor function in mild-to-moderate PwP, while two infusions showed less improvement than placebo. To address this discrepancy, future studies should conduct functional potency assays to understand batch-to-batch variability affecting clinical efficacy. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. 6

Key numbers

16.9

Improvement in (Three Infusions)

Mean difference in scores at week 62.

14.6

Improvement in (Placebo)

Mean difference in scores at week 62.

3.9

Improvement in (Two Infusions)

Mean difference in scores at week 62.

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Using Donor Stem Cells from Bone Marrow to Treat Parkinson's Disease: A Randomized Trial

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