Table 5 Clinical trials of hAECs transplantation registered at http://ClinicalTrials.gov
From: Application of human amniotic epithelial cells in regenerative medicine: a systematic review
| Â | Study | Disease | Design | Start date | Status | Phase | Estimated enrollment | Intervention | ClinicalTrials.gov identifier |
|---|---|---|---|---|---|---|---|---|---|
1 | Human Amniotic Epithelial Cell in Treatment of Refractory Severe Intrauterine Adhesion | Intrauterine adhesion | Safety and effectiveness | March 2018 | Not yet recruiting | 1 | 20 | Uterine cavity infusion (100 million) | NCT03381807 |
2 | Human Amniotic Epithelial Cells for Asherman’s Syndrome | Asherman’s syndrome | Safety and effectiveness | October 2017 | Not yet recruiting | 1 | 50 | Biological amnion; biological amnion loaded with hAECs (100 million); intravenous infusion (100 million); intrauterine infusion (100 million); hydrogel loaded with hAECs (100 million) | NCT03223454 |
3 | A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Insufficiency Patients | Primary ovarian insufficiency/premature ovarian failure/infertility | Safety and effectiveness | June 2020 | Recruiting | 1 | 36 | Bilateral ovarian artery infusion (2 × 107 cells) | NCT02912104 |
4 | Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency | Premature ovarian failure | Safety and effectiveness | December 2017 | Not yet recruiting | Not applicable | 20 | Minimally invasive implantation (200 million); intravenous infusion (100 million for 3 times) | NCT03207412 |
5 | Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula | Bronchial fistula | Therapeutic potential | October 2016 | Recruiting | 1 | 10 | Endoscopic injection of hAECs to fistula (3–5 × 107 cells) | NCT02959333 |
6 | Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy | Spastic cerebral palsy | Therapeutic potential | April 2017 | Enrolling by invitation | 1 | 10 | Intrathecal injection | NCT03107975 |
7 | Treatment of Non-union of Limb Fracture with Human Amniotic Epithelial Cells (hAECs) | Non-union fracture | Safety and efficacy | December 2017 | Not yet recruiting | 1/2 | 36 | Transplant to non-union site (50 million) | NCT03031509 |
8 | hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation | Leukemia | Observational | July 2020 | Recruiting | Not applicable | 30 | Unknown | NCT03759899 |
9 | Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation | Acute graft-versus-host disease | Safety and efficacy | July 2020 | Recruiting | Not applicable | 27 | Infusion of hAECs (1 × 106, 2 × 106, 5 × 106 cell/kg) | NCT03764228 |