How strong is the evidence for stem-cell therapy in Back Pain & Disc Degeneration?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: the registry holds 35 records, 15 completed, 2 at Phase 3 or 4, and 7 stopped early (20%). MSC-specific work accounts for 20 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 Back Pain & Disc Degeneration
A convincing result shows a difference against sham injection on a validated pain and disability score at twelve months. Back pain improves substantially with saline injections in controlled trials, so anything without a sham arm is measuring hope, procedure effect and natural history together.
What we can say from registrations alone
- Volume: 35 registered studies since 2007.
- Maturity: 2 confirmatory-phase records.
- Delivery: 15 completed; 7 terminated, withdrawn or suspended.
- Scale: median planned enrolment 24 participants, largest 404.
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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT01290367 — Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain | Phase 2 | Completed | 100 | Mesoblast, Ltd. | 2011-08 |
| NCT03347708 — Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration | Phase 1 | Completed | 60 | DiscGenics, Inc. | 2018-02-26 |
| NCT04759105 — Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD | Phase 2 | Completed | 48 | Fondazione Policlinico Universitario Campus Bio-Medico | 2019-11-03 |
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 "Back Pain & Disc Degeneration 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 Back Pain & Disc Degeneration?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: 35 registered records, 2 at Phase 3/4 and 7 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
That has to be checked per product with the regulator that governs where you would be treated. A clinic's own claim of approval is not verification.
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
- 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