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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02644447
Other study ID # CAS-XDA-POF/IGDB
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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