What research stage is stem-cell therapy for Peripheral Neuropathy at?
The ladder for this condition: 2 Phase 3 or 4 records out of 50 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 23 | 37% |
| Phase 1 | 20 | 32% |
| Not applicable | 15 | 24% |
| Early Phase 1 | 3 | 5% |
| Phase 3 | 2 | 3% |
What the phase mix means for Peripheral Neuropathy
Registrations remain early-phase and modest in size. The natural regenerative capacity of peripheral nerve makes untreated improvement common, which small single-arm trials cannot distinguish from treatment effect.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT00434616 — Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia | Phase 2, Phase 3 | Unknown | 90 | Franziskus-Krankenhaus | 2007-04 |
| 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
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 42 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 |
|---|---|---|---|---|---|
| NCT04684602 — Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions | Phase 1, Phase 2 | Recruiting | 5,000 | Thomas Advanced Medical LLC | 2020-07-09 |
| 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 |
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT02796079 — A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
| NCT02831075 — A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
Frequently asked
What research stage is stem-cell therapy for Peripheral Neuropathy at?
2 of 50 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
- Peripheral Neuropathy: cell-therapy evidence and registered trials
- How much does stem cell therapy for Peripheral Neuropathy cost? (2026)
- Peripheral Neuropathy stem cell therapy — your questions answered (2026)
- Peripheral Neuropathy: cell-therapy evidence by therapy class
- MSC vs PRP for Peripheral Neuropathy: what the registries show