Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Chinese Academy of Sciences23 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Premature Ovarian Failure

Interventions

HUC-MSCs TransplantationBIOLOGICAL

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

HUC-MSCs with Injectable Collagen Scaffold TransplantationBIOLOGICAL

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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