Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure

Summary

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

Timeline

Start

2015-10

Primary completion

2020-06-25

Completion

2020-07-22

Outcome

Mixed primary results

registry analysis (superiority test); MSCs + CPCs vs Placebo; p = 0.993; Mean Difference (Final Values) -0.08 (95% CI -2.190 to 2.023); ANCOVA NCT02501811 ↗

registry Lower scores indicative of better outcomes. NCT02501811 ↗

registry analysis (superiority test); MSCs + CPCs vs Placebo; p = 0.023; Mean Difference (Final Values) -9.64 (95% CI -18.915 to -0.357); ANCOVA NCT02501811 ↗

Publications

• Background Hare JM, Bolli R, Cooke JP, Gordon DJ, Henry TD, Perin EC, March KL, Murphy MP, Pepine CJ, Simari RD, Skarlatos SI, Traverse JH, Willerson JT, Szady AD, Taylor DA, Vojvodic RW, Yang PC, Moye LA; Cardiovascular Cell Therapy Research Network. Phase II clinical research design in cardiology: learning the right lessons too well: observations and recommendations from the Cardiovascular Cell Therapy Research Network (CCTRN). Circulation. 2013 Apr 16;127(15):1630-5. doi: 10.1161/CIRCULATIONAHA.112.000779. No abstract available.
• Background Nazarian S, Halperin HR. How to perform magnetic resonance imaging on patients with implantable cardiac arrhythmia devices. Heart Rhythm. 2009 Jan;6(1):138-43. doi: 10.1016/j.hrthm.2008.10.021. Epub 2008 Oct 22. No abstract available.
• Background Bolli R, Hare JM, March KL, Pepine CJ, Willerson JT, Perin EC, Yang PC, Henry TD, Traverse JH, Mitrani RD, Khan A, Hernandez-Schulman I, Taylor DA, DiFede DL, Lima JAC, Chugh A, Loughran J, Vojvodic RW, Sayre SL, Bettencourt J, Cohen M, Moye L, Ebert RF, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure). Circ Res. 2018 Jun 8;122(12):1703-1715. doi: 10.1161/CIRCRESAHA.118.312978. Epub 2018 Apr 27.
• Chacon-Alberty L, Tan X, Li M, Tang XL, Hochman-Mendez C, Bolli R. Changes in Circulating Biomarkers in Patients With Ischemic Heart Failure After Treatment With Autologous Mesenchymal Stromal Cells and c-Kit-Positive Cardiac Cells, Alone or in Combination: Results From the Cardiovascular Cell Therapy Research Network CONCERT-HF Clinical Trial. J Am Heart Assoc. 2026 May 5;15(9):e045963. doi: 10.1161/JAHA.125.045963. Epub 2026 Apr 20.
• Kato Y, Kizer JR, Ostovaneh MR, Lazar J, Peng Q, van der Geest RJ, Lima JAC, Ambale-Venkatesh B. Extracellular volume-guided late gadolinium enhancement analysis for non-ischemic cardiomyopathy: The Women's Interagency HIV Study. BMC Med Imaging. 2021 Jul 27;21(1):116. doi: 10.1186/s12880-021-00649-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	c-kit+ cells	Unknown	5 cells	Other
Subject	mesenchymal stem cells	Cell therapy	150 cells	Other

Indications