What research stage is stem-cell therapy for Hair Loss & Restoration at?
The ladder for this condition: 2 Phase 3 or 4 records out of 17 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Not applicable | 10 | 50% |
| Phase 2 | 5 | 25% |
| Phase 1 | 3 | 15% |
| Phase 3 | 1 | 5% |
| Phase 4 | 1 | 5% |
What the phase mix means for Hair Loss & Restoration
Phase labels are unreliable here because many studies are registered as device or cosmetic protocols. Where phase ladders do apply, the field remains early despite the volume of commercial activity.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03388840 — Adipose Derived Stem Cells Versus Platelet Rich Plasma on Follicular Unit Extraction | Phase 4 | Unknown | 40 | Assiut University | 2018-01-15 |
| NCT05296863 — Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia | Phase 3 | Completed | 37 | Dr. dr. Lili Legiawati, SpKK(K) | 2021-10-11 |
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 48 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 |
|---|---|---|---|---|---|
| NCT07693244 — Exosome Therapy for Male Androgenetic Alopecia | Phase 2 | Recruiting | 120 | Zhang Han | 2026-04-30 |
| NCT03676400 — Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia | n/a | Completed | 84 | Medipost Co Ltd. | 2018-10-02 |
| NCT05129800 — Efficacy of Platelet-Rich Plasma Versus Mesotherapy in Androgenetic Alopecia: A Retrospective Study | n/a | Completed | 72 | Faculty Hospital Kralovske Vinohrady | 2011-01-01 |
| NCT06764329 — The Effectiveness of Allogenic Mesenchymal Stem Cells Therapy on Hair Regrowth in Androgenetic Alopecia. | Phase 1, Phase 2 | Enrolling By Invitation | 70 | National Institute of Blood and Marrow Transplant (NIBMT), P | 2024-12-25 |
| NCT07107841 — Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site) | n/a | Recruiting | 60 | Acorn Biolabs Inc. | 2025-10-16 |
Frequently asked
What research stage is stem-cell therapy for Hair Loss & Restoration at?
2 of 17 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.