Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Premature Ovarian Failure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644447
• Other study ID #: CAS-XDA-POF/IGDB
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: December 2015
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• HUC-MSCs Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Estradiol (E2) serum level	Serum E2 level was evaluated after surgery.	Once a week within 3 months after the surgery
Secondary	Follicle Stimulating Hormone (FSH) serum level	Serum FSH level was evaluated after surgery.	Once a week within 3 months after the surgery
Secondary	Anti-Mullerian Hormone (AMH) serum level	Serum AMH level was evelated after surgery.	Once a week within 3 months after the surgery
Secondary	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