What research stage is stem-cell therapy for Premature Ovarian Insufficiency at?
Of 36 registrations, 3 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 21 | 41% |
| Phase 2 | 17 | 33% |
| Not applicable | 10 | 20% |
| Phase 4 | 2 | 4% |
| Phase 3 | 1 | 2% |
What the phase mix means for Premature Ovarian Insufficiency
Registrations are early and small. Given that pregnancy is a binary, verifiable endpoint, the lack of controlled later-phase work is telling.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04475744 — 4-step ASCOT in POI Women to Promote Follicular Rescue | Phase 3 | Completed | 42 | Fundación IVI | 2021-03-05 |
| NCT03535480 — Autologous Bone Marrow Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian Failure | Phase 4 | Unknown | 20 | Instituto de Investigacion Sanitaria La Fe | 2018-06 |
| NCT01853501 — Effects of ADSC Therapy in Women With POF | Phase 4 | Unknown | 4 | Nanjing University | 2012-09 |
How to read phase labels
The ladder runs from tolerability through signal-finding to a controlled, adequately powered test of benefit. Cell-therapy records frequently carry no phase at all, because observational designs and some tissue-based protocols sit outside the drug framework entirely. Read that as a classification gap, not a verdict.
Median planned enrolment across sampled studies here is 40 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 |
|---|---|---|---|---|---|
| NCT03033277 — Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI) | Phase 1, Phase 2 | Unknown | 320 | Chinese Academy of Sciences | 2016-02 |
| NCT05667428 — A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT | n/a | Unknown | 200 | First Affiliated Hospital Xi'an Jiaotong University | 2023-03-01 |
| NCT02372474 — "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure | Phase 1, Phase 2 | Completed | 112 | Al-Azhar University | 2012-03 |
| NCT04009473 — Stem Cell Therapy and Growth Factor Ovarian in Vitro Activation | Phase 1, Phase 2 | Unknown | 100 | Forever Young d.o.o. | 2019-06-01 |
| NCT04675970 — Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy | n/a | Completed | 86 | Ukraine Association of Biobank | 2020-09-01 |
Frequently asked
What research stage is stem-cell therapy for Premature Ovarian Insufficiency at?
3 of 36 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
- Premature Ovarian Insufficiency: cell-therapy evidence and registered trials
- How much does stem cell therapy for Premature Ovarian Insufficiency cost? (2026)
- Premature Ovarian Insufficiency stem cell therapy — your questions answered (2026)
- Premature Ovarian Insufficiency: cell-therapy evidence by therapy class
- MSC vs PRP for Premature Ovarian Insufficiency: what the registries show