Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Phase 1

Completed

• Conditions: Premature Ovarian Failure

• Registration Number: NCT02644447
• Lead Sponsor: Chinese Academy of Sciences

Brief 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).

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

1. Diagnosed with Premature Ovarian Failure.
2. Patients show no response to drug treatment
3. Women between 20 and 39 years.
4. Willing to sign the Informed Consent Form.

Exclusion Criteria

1. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
2. Congenital ovarian malformation.
3. Severe endometriosis.
4. Thyroid dysfunction.
5. Contraindications for pregnancy.
6. Contraindications for hormone replacement therapy.
7. Prior personal history of ovarian cancer or after radiotherapy.
8. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability assessed by Adverse Events	Up to 6 months	Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.

Secondary Outcome Measures

Name	Time	Method
Follicle Stimulating Hormone (FSH) serum level	Once a week within 3 months after the surgery	Serum FSH level was evaluated after surgery.
Number of Antral follicle development	Once a week within 3 months after the surgery	The number of follicles developing was recorded by transvaginal ultrasound scan.
Estradiol (E2) serum level	Once a week within 3 months after the surgery	Serum E2 level was evaluated after surgery.
Anti-Mullerian Hormone (AMH) serum level	Once a week within 3 months after the surgery	Serum AMH level was evelated after surgery.
Pregnancy rate	2 weeks after embryo implantation	The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China