What research stage is stem-cell therapy for Spinal Cord Injury at?
Confirmatory-phase work accounts for 3 of the 70 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 39 | 42% |
| Phase 2 | 37 | 40% |
| Not applicable | 10 | 11% |
| Early Phase 1 | 4 | 4% |
| Phase 3 | 3 | 3% |
What the phase mix means for Spinal Cord Injury
Registrations remain early-phase, with small cohorts and long follow-up requirements. Spontaneous recovery in the first year after injury is substantial, which is why uncontrolled early-treatment reports are so difficult to interpret.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT01873547 — Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China | Phase 3 | Completed | 300 | General Hospital of Chinese Armed Police Forces | 2012-06 |
| NCT01676441 — Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury | Phase 2, Phase 3 | Terminated | 20 | Pharmicell Co., Ltd. | 2008-08 |
| NCT03935724 — Stem Cells in Spinal Cord Injury | Phase 2, Phase 3 | Unknown | 16 | Neuroplast | 2022-01-18 |
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 18 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 |
|---|---|---|---|---|---|
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT01873547 — Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China | Phase 3 | Completed | 300 | General Hospital of Chinese Armed Police Forces | 2012-06 |
| 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 |
| NCT02481440 — Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI | Phase 1, Phase 2 | Completed | 102 | Limin Rong | 2018-03-30 |
| NCT03521336 — Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury | Phase 2 | Unknown | 84 | Third Affiliated Hospital, Sun Yat-Sen University | 2019-09-01 |
Frequently asked
What research stage is stem-cell therapy for Spinal Cord Injury at?
3 of 70 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
- Spinal Cord Injury: cell-therapy evidence and registered trials
- How much does stem cell therapy for Spinal Cord Injury cost? (2026)
- Spinal Cord Injury stem cell therapy — your questions answered (2026)
- Spinal Cord Injury: cell-therapy evidence by therapy class
- MSC vs HSCT for Spinal Cord Injury: what the registries show