What research stage is stem-cell therapy for Back Pain & Disc Degeneration at?
Of 35 registrations, 2 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 15 | 34% |
| Not applicable | 15 | 34% |
| Phase 1 | 11 | 25% |
| Phase 3 | 2 | 5% |
| Early Phase 1 | 1 | 2% |
What the phase mix means for Back Pain & Disc Degeneration
Back-pain cell studies reached mid-phase designs relatively quickly, helped by short follow-up windows and simple pain endpoints. That advantage is also a weakness: short trials in a condition that fluctuates naturally can produce impressive-looking curves in both arms.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02412735 — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain | Phase 3 | Completed | 404 | Mesoblast, Ltd. | 2015-03-06 |
| NCT04559295 — Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs | Phase 2, Phase 3 | Unknown | 80 | Stem Cures | 2018-11-21 |
How to read phase labels
Phase 1 asks whether a dose is tolerated, usually in a small group without a control arm. Phase 2 looks for a signal and refines dosing. Phase 3 is confirmatory: larger, controlled, powered to test whether the intervention changes an outcome that matters. Not applicable appears for observational studies or where the sponsor assigned no phase, which is common in cell therapy and not a quality mark either way.
Median planned enrolment across sampled studies here is 24 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 |
|---|---|---|---|---|---|
| NCT02412735 — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain | Phase 3 | Completed | 404 | Mesoblast, Ltd. | 2015-03-06 |
| NCT00974623 — Bone Graft Materials Observational Registry | n/a | Terminated | 329 | Baxter Healthcare Corporation | 2009-09 |
| NCT00965380 — Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF) | n/a | Completed | 207 | Orthofix Inc. | 2009-09 |
| NCT00951938 — Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) | n/a | Completed | 200 | Orthofix Inc. | 2009-08 |
| NCT03390920 — Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions | n/a | Not Yet Recruiting | 200 | R3 Stem Cell | 2022-01-01 |
Frequently asked
What research stage is stem-cell therapy for Back Pain & Disc Degeneration at?
2 of 35 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
- Back Pain & Disc Degeneration: cell-therapy evidence and registered trials
- How much does stem cell therapy for Back Pain & Disc Degeneration cost? (2026)
- Back Pain & Disc Degeneration stem cell therapy — your questions answered (2026)
- Back Pain & Disc Degeneration: cell-therapy evidence by therapy class