Allogeneic bone marrow-derived mesenchymal stem cells in the aging kidney: secondary results of a Parkinson's disease clinical trial.

BACKGROUND

Kidney function declines with age, largely due to chronic low-grade inflammation. Mesenchymal stem cells (MSCs) have demonstrated immunomodulatory effects in certain immune-mediated kidney diseases, but their role in preserving renal function in aging individuals without chronic kidney disease (CKD) remains unclear. This study presents secondary outcome findings from a randomized clinical trial in Parkinson's disease (PD), evaluating the impact of allogeneic human bone marrow-derived MSCs (allo-hMSCs) on kidney function in an aging population with PD with preserved renal function.

METHODS

Subjects with PD aged 50-79 years with baseline estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 were randomized to receive either three allo-hMSC infusions, one placebo followed by two allo-hMSC infusions, or three placebo infusions at 18-week intervals. Kidney function was assessed using eGFR, serum creatinine (SCr), and blood urea nitrogen (BUN) at baseline, 9 weeks after the first two infusions, and at weeks 40 and 88. eGFR was calculated using the 2021 CKD-EPI equation. A Bayesian modeling approach was used to estimate posterior probabilities (PP) of treatment effects.

RESULTS

Of 45 randomized patients, 44 were analyzed; 43 completed infusions, and 40 completed the 88-week follow-up. The three-infusion group (N = 16) showed an average annual eGFR increase of 3.29 mL/min/1.73 m2, versus declines of -1.46 and -2.92 in the two-infusion (N = 14) and placebo (N = 15) groups. SCr decreased by -0.12 mg/dL at both weeks 40 (PP: 93.9%) and 88 (PP: 86.2%) in the three-infusion group versus placebo, with no significant SCr differences between the two-infusion and placebo groups. BUN levels did not differ significantly between treatment and placebo groups.

CONCLUSION

In older adults with PD and preserved kidney function, repeated allo-hMSC infusions were associated with improved kidney function measures. While promising, these findings are preliminary and may be specific to PD. Further studies are needed to assess potential benefits in the broader aging population.

TRIAL REGISTRATION: ClinicalTrials.Gov. NCT04506073. November 09, 2020. https://clinicaltrials.gov/study/NCT04506073.