Trials / Completed
CompletedNCT02644447
Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF
The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Chinese Academy of Sciences · Other Government
- Sex
- Female
- Age
- 20 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.
Detailed description
The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HUC-MSCs Transplantation | The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs. |
| BIOLOGICAL | HUC-MSCs with Injectable Collagen Scaffold Transplantation | The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2015-12-31
- Last updated
- 2020-01-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02644447. Inclusion in this directory is not an endorsement.