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NCT02912104: POF

A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure

Completed Phase 1 Last updated 1 March 2023
What this trial tests

Phase 1 trial testing human amniotic epithelial cells (hAECs) transplantation in Primary Ovarian Insufficiency in 36 participants. Completed in 5 January 2023.

Timeline
20 June 2020
Primary endpoint
5 January 2022
5 January 2023

Quick facts

Lead sponsorInternational Peace Maternity and Child Health Hospital
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date20 June 2020
Primary completion5 January 2022
Estimated completion5 January 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

International Peace Maternity and Child Health Hospital

Who can join

Adults 18 to 45, female only, with Primary Ovarian Insufficiency or Premature Ovarian Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project will clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian failure (POF) patients and provide a new therapeutic method for patients with infertility.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Applications of Human Amniotic Membrane for Tissue Engineering.
    Fénelon M, Catros S, Meyer C, Fricain JC, et al · · 2021 · cited 83× · PMID 34070582 · DOI 10.3390/membranes11060387
  2. Characteristics and Therapeutic Potential of Human Amnion-Derived Stem Cells.
    Liu QW, Huang QM, Wu HY, Zuo GS, et al · · 2021 · cited 77× · PMID 33478081 · DOI 10.3390/ijms22020970
  3. Application of human amniotic epithelial cells in regenerative medicine: a systematic review.
    Zhang Q, Lai D. · · 2020 · cited 75× · PMID 33059766 · DOI 10.1186/s13287-020-01951-w
  4. Human Amniotic Epithelial Stem Cells: A Promising Seed Cell for Clinical Applications.
    Qiu C, Ge Z, Cui W, Yu L, et al · · 2020 · cited 50× · PMID 33086620 · DOI 10.3390/ijms21207730
  5. Amniotic fluid characteristics and its application in stem cell therapy: A review.
    Shamsnajafabadi H, Soheili ZS. · · 2022 · cited 20× · PMID 36313262 · DOI 10.18502/ijrm.v20i8.11752
  6. Human placenta-derived amniotic epithelial cells as a new therapeutic hope for COVID-19-associated acute respiratory distress syndrome (ARDS) and systemic inflammation.
    Babajani A, Moeinabadi-Bidgoli K, Niknejad F, Rismanchi H, et al · · 2022 · cited 17× · PMID 35337387 · DOI 10.1186/s13287-022-02794-3
  7. A Survey and Critical Evaluation of Isolation, Culture, and Cryopreservation Methods of Human Amniotic Epithelial Cells.
    Naeem A, Gupta N, Arzoo N, Naeem U, et al · · 2022 · cited 9× · PMID 35289707 · DOI 10.1080/15384101.2021.2020015
  8. Safety and efficacy of allogenic human amniotic epithelial cells transplantation via ovarian artery in patients with premature ovarian failure: a single-arm, phase 1 clinical trial.
    Weng L, Wei L, Zhang Q, Sun T, et al · · 2024 · cited 8× · PMID 39165278 · DOI 10.1016/j.eclinm.2024.102744

Verify or expand the search:

Other recruiting trials for Primary Ovarian Insufficiency

Currently open trials in the same condition.

Other International Peace Maternity and Child Health Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02912104.

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