EXCELLENT (EXpanded CELL ENdocardiac Transplantation)

Summary

A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.

Timeline

Start

2016-02-10

Primary completion

2024-03-15

Completion

2024-03-15

Publications

• Background Roncalli J, Roubille F, Henon P, Marie PY, Montalescot G, Bhatt DL, Trebuchet G, de Kalbermatten M, Garitaonandia I, Smadja DM. TransEndocardial Injection of Autologous Expanded CD34+ Stem Cells (ProtheraCytes(R)) after myocardial infarction: Impact on Patients' Quality of Life. Stem Cell Rev Rep. 2026 May;22(4):1800-1810. doi: 10.1007/s12015-026-11098-5. Epub 2026 Mar 3.
• Background Roncalli J, Roubille F, Meyer N, Pompilio G, Leroux L, Henon P, Trebuchet G, Criquet A, de Kalbermatten M, Saloux E, Manrique A, Marie PY, Bhatt DL, Solomon SD, Montalescot G, Newby DE, Zannad F; EXCELLENT Trial Investigators. Transendocardial injection of expanded autologous CD34+ cells after myocardial infarction: Design of the EXCELLENT trial. ESC Heart Fail. 2025 Apr;12(2):1455-1463. doi: 10.1002/ehf2.15124. Epub 2024 Dec 15.
• Results Roncalli J, Roubille F, Cottin Y, Leroux L, Mathur A, Irving J, Khan SQ, Meneveau N, Bresson D, Hovasse T, Pompilio G, Matta A, Henon P, Trebuchet G, de Kalbermatten M, Garitaonandia I, Saloux E, Manrique A, Meyer N, Marie PY, Bhatt DL, Solomon SD, Montalescot G, Newby DE, Zannad F; EXCELLENT Trial Investigators. Transendocardial Injection of Expanded Autologous CD34+ Cells After Myocardial Infarction: Results of the EXCELLENT Trial. JACC Heart Fail. 2025 Nov;13(11):102626. doi: 10.1016/j.jchf.2025.102626. Epub 2025 Sep 9. No abstract available.
• Bouis D, Goubaud A, Cormier A, Bennaoum S, Destalminil M, Schaffhauser H, Vignon C, de Kalbermatten M, Garitaonandia I. Development and Validation of Flow Cytometry-Based Method to Quantify CD34/CD45+ Cells as a Release Criterion of Clinical-Grade Products for a Phase III Clinical Trial. Cytometry A. 2026 Apr;109(4):273-289. doi: 10.1002/cyto.a.70028. Epub 2026 May 3.
• Borlongan CV, Lee JY, D'Egidio F, de Kalbermatten M, Garitaonandia I, Guzman R. Nose-to-brain delivery of stem cells in stroke: the role of extracellular vesicles. Stem Cells Transl Med. 2024 Nov 12;13(11):1043-1052. doi: 10.1093/stcltm/szae072.
• Aries A, Vignon C, Zanetti C, Goubaud A, Cormier A, Diederichs A, Lahlil R, Henon P, Garitaonandia I. Development of a potency assay for CD34+ cell-based therapy. Sci Rep. 2023 Nov 11;13(1):19665. doi: 10.1038/s41598-023-47079-8.

Drugs

Indications