What research stage is stem-cell therapy for Heart Failure & Cardiac Repair at?
The ladder for this condition: 18 Phase 3 or 4 records out of 125 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 66 | 41% |
| Phase 1 | 59 | 36% |
| Not applicable | 18 | 11% |
| Phase 3 | 15 | 9% |
| Phase 4 | 3 | 2% |
| Early Phase 1 | 1 | 1% |
What the phase mix means for Heart Failure & Cardiac Repair
This indication carries one of the deeper later-phase records in cell therapy, including large trials that failed to meet primary endpoints. That history is the useful part: it shows the field can run confirmatory studies, and what happens when it does.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02032004 — Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure | Phase 3 | Completed | 565 | Mesoblast, Inc. | 2014-03-03 |
| NCT05043610 — MSCs for Prevention of MI-induced HF | Phase 3 | Completed | 420 | Shiraz University of Medical Sciences | 2021-09-15 |
| NCT01569178 — BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction | Phase 3 | Completed | 375 | Queen Mary University of London | 2013-09 |
| NCT00841958 — Endocardial Stem Cells Approach Efficacy | Phase 3 | Completed | 250 | Meshalkin Research Institute of Pathology of Circulation | 2007-02 |
| NCT02323620 — Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI | Phase 3 | Unknown | 200 | American Heart of Poland | 2019-03 |
| NCT00526253 — To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction | Phase 2, Phase 3 | Unknown | 170 | Bioheart, Inc. | 2007-09 |
How to read phase labels
Early phases exist to find harm and set a dose. They are not built to detect benefit, and they routinely produce encouraging-looking numbers that later trials fail to reproduce. Only a confirmatory design with a comparison arm can separate the intervention from everything else happening to a patient.
Median planned enrolment across sampled studies here is 30 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | Phase 1 | Not Yet Recruiting | 5,000 | R3 Stem Cell | 2019-09-01 |
| NCT02032004 — Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure | Phase 3 | Completed | 565 | Mesoblast, Inc. | 2014-03-03 |
| NCT05043610 — MSCs for Prevention of MI-induced HF | Phase 3 | Completed | 420 | Shiraz University of Medical Sciences | 2021-09-15 |
| NCT01569178 — BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction | Phase 3 | Completed | 375 | Queen Mary University of London | 2013-09 |
| NCT00841958 — Endocardial Stem Cells Approach Efficacy | Phase 3 | Completed | 250 | Meshalkin Research Institute of Pathology of Circulation | 2007-02 |
Frequently asked
What research stage is stem-cell therapy for Heart Failure & Cardiac Repair at?
18 of 125 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Heart Failure & Cardiac Repair: cell-therapy evidence and registered trials
- How much does stem cell therapy for Heart Failure & Cardiac Repair cost? (2026)
- Heart Failure & Cardiac Repair stem cell therapy — your questions answered (2026)
- Heart Failure & Cardiac Repair: cell-therapy evidence by therapy class
- MSC vs HSCT for Heart Failure & Cardiac Repair: what the registries show