How strong is the evidence for stem-cell therapy in Heart Failure & Cardiac Repair?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 125 records, 54 completed, 18 at Phase 3 or 4, and 23 stopped early (18%). MSC-specific work accounts for 32 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Heart Failure & Cardiac Repair
The endpoints that matter are mortality, hospitalisation and change in ejection fraction measured by a blinded imaging core lab, over a year or more. Six-minute-walk gains in unblinded studies have repeatedly failed to survive controlled replication.
What we can say from registrations alone
- Volume: 125 registered studies since 2002.
- Maturity: 18 confirmatory-phase records.
- Delivery: 54 completed; 23 terminated, withdrawn or suspended.
- Scale: median planned enrolment 30 participants, largest 5,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| 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 |
| NCT01270139 — Plasmonic Nanophotothermal Therapy of Atherosclerosis | n/a | Completed | 180 | Ural State Medical University | 2007-04-01 |
| NCT00747708 — Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure | Phase 2, Phase 3 | Completed | 148 | Barts & The London NHS Trust | 2005-08 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Heart Failure & Cardiac Repair research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Heart Failure & Cardiac Repair?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 125 registered records, 18 at Phase 3/4 and 23 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Look it up at source: regulators publish authorised products and indications. Registration of a trial, a licence to operate a clinic and product approval are three different things.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
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