Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

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)

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.

Study Overview

• Status: Completed
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Biological: HUC-MSCs Transplantation; Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HUC-MSCs Transplantation	Biological: HUC-MSCs Transplantation; The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
Experimental: HUC-MSCs with Injectable Collagen Scaffold Transplantation	Biological: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: CAS-XDA-POF/IGDB