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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HUC-MSCs Transplantation | Experimental |
| |
| HUC-MSCs with Injectable Collagen Scaffold Transplantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HUC-MSCs Transplantation | Biological | The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability assessed by Adverse Events | Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Antral follicle development | The number of follicles developing was recorded by transvaginal ultrasound scan. | Once a week within 3 months after the surgery |
| Estradiol (E2) serum level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| HUC-MSCs with Injectable Collagen Scaffold Transplantation | Biological | The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold. |
|
Serum E2 level was evaluated after surgery.
| Once a week within 3 months after the surgery |
| Follicle Stimulating Hormone (FSH) serum level | Serum FSH level was evaluated after surgery. | Once a week within 3 months after the surgery |
| Anti-Mullerian Hormone (AMH) serum level | Serum AMH level was evelated after surgery. | Once a week within 3 months after the surgery |
| Pregnancy rate | The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection. | 2 weeks after embryo implantation |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |