Premature Ovarian Insufficiency and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 9 records for HSCT in Premature Ovarian Insufficiency: 0 recruiting now, 1 labelled Phase 3 or 4, across 7 countries. Snapshot 2026-08-29.
Why this is studied in Premature Ovarian Insufficiency
Primary ovarian insufficiency is loss of ovarian function before forty, from genetic, autoimmune or iatrogenic causes. Cell and platelet-based 'ovarian rejuvenation' aims to restore folliculogenesis. Occasional spontaneous ovulation occurs in this condition — including spontaneous pregnancies — which is the fact most often exploited by uncontrolled case reports.
What HSCT means in this table
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
The numbers
Every figure below comes from one reproducible query (primary ovarian insufficiency x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 9 |
| Interventional studies in the sample | 9 |
| Recruiting right now | 0 |
| Completed | 4 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 or Phase 4 records | 1 |
| Countries with at least one site | 7 |
| Median planned enrolment | 51 participants |
| Largest single planned enrolment | 200 participants |
| First / most recent start year | 2002 — 2025 |
How mature is this evidence?
A small later-stage tail exists (1 of 9 records at Phase 3 or 4); the centre of gravity is still Phase 1 and 2 work sized for safety rather than proof of benefit.
4 records are marked completed and 0 ended early (terminated, withdrawn or suspended): 0% of registrations did not run to plan.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 6 | 43% |
| Phase 1 | 5 | 36% |
| Not applicable | 2 | 14% |
| Phase 4 | 1 | 7% |
Median planned enrolment is 51 participants (largest single study: 200). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
The work is distributed across 7 countries; Egypt alone accounts for about 33% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.
| Country | Studies with a site there |
|---|---|
| Egypt | 3 |
| United States | 1 |
| France | 1 |
| Spain | 1 |
| China | 1 |
| Jordan | 1 |
| Iran | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is academic (4 academic or hospital, 3 commercial among the most frequent lead sponsors).
- Al-Azhar University — 2 records
- M.D. Anderson Cancer Center — 1 record
- University Hospital, Bordeaux — 1 record
- Instituto de Investigacion Sanitaria La Fe — 1 record
- First Affiliated Hospital Xi'an Jiaotong University — 1 record
- Stem Cells Arabia — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| 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 |
| NCT03069209 — Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF) | Phase 1, Phase 2 | Unknown | 50 | Stem Cells Arabia | 2015-01 |
| NCT02603744 — Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF) | Phase 1, Phase 2 | Unknown | 9 | Royan Institute | 2015-06 |
| NCT02043743 — Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure | Phase 1, Phase 2 | Unknown | 60 | El-Rayadh Fertility Centre | 2014-01 |
| 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 |
| NCT02151890 — Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure | Phase 1, Phase 2 | Completed | 10 | Al-Azhar University | 2012-03 |
| NCT00429494 — GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients | Phase 2 | Completed | 60 | M.D. Anderson Cancer Center | 2002-11 |
| NCT07048730 — Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults | n/a | Completed | 51 | University Hospital, Bordeaux | 2025-09-19 |
| 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 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many HSCT studies for Premature Ovarian Insufficiency are recruiting right now?
0 of 9 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT an approved treatment for Premature Ovarian Insufficiency?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 9 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Premature Ovarian Insufficiency?
1 of 9 records carry a Phase 3 or Phase 4 label and 4 are marked completed. Registrations run from 2002 to 2025.
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
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.