A Phase 1/2 interventional study of HUC-MSCs Transplantation and HUC-MSCs with Injectable Collagen Scaffold Transplantation in Premature Ovarian Failure, sponsored by Chinese Academy of Sciences. Completed at 1 site in China. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Chinese Academy of Sciences · Phase 1/2, Interventional, and Treatment
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).
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 23 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Biological: HUC-MSCs Transplantation
Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
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.
Time frame: Up to 6 months
Number of Antral follicle development
The number of follicles developing was recorded by transvaginal ultrasound scan.
Time frame: Once a week within 3 months after the surgery
Estradiol (E2) serum level
Serum E2 level was evaluated after surgery.
Time frame: Once a week within 3 months after the surgery
Follicle Stimulating Hormone (FSH) serum level
Serum FSH level was evaluated after surgery.
Time frame: Once a week within 3 months after the surgery
Anti-Mullerian Hormone (AMH) serum level
Serum AMH level was evelated after surgery.
Time frame: 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.
Time frame: 2 weeks after embryo implantation
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Sciences