Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: HUC-MSCs Transplantation
* Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Premature Ovarian Failure. Patients show no response to drug treatment Women between 20 and 39 years. Willing to sign the Informed Consent Form. Exclusion Criteria: Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome). Congenital ovarian malformation. Severe endometriosis. Thyroid dysfunction. Contraindications for pregnancy. Contraindications for hormone replacement therapy. Prior personal history of ovarian cancer or after radiotherapy. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HUC-MSCs Transplantation<br> | Biological: HUC-MSCs Transplantation<br>* The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.<br>|
| Experimental: HUC-MSCs with Injectable Collagen Scaffold Transplantation<br> | Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation<br>* The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |