Transplantation of hAMSCs for Woman With DOR

The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown promise in treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human Amniotic Mesenchymal Stem Cells(hAMSCs) in women suffered from infertility caused by DOR.

Study Overview

• Status: Not yet recruiting
• Conditions: Diminished Ovarian Response
• Intervention / Treatment: Other: stem cells

Detailed Description

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown immense promise in the treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human amniotic mesenchymal stem cells(hAMSCs) in women suffered from infertility caused by DOR. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiang Ma, Doctor; Phone Number: +8618001581878; Email: sxmaxiang@126.com
• Study Contact Backup: Name: Lianju Qin, Doctor; Phone Number: +86 18012923584; Email: ljqin@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University
      • Contact: Xiang Ma; Phone Number: 8613770681878
      • Contact: Lianju Qin; Phone Number: 8618012923584

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women between35 and 45 years, who is diagnosed with Diminished Ovarian Reserve by Bologna criteria, (AFC≤7，or serum AMH level < 1.10ng/ml), and failed pregnancies in at least two cycles of In Vitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI).
2. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
2. Patients allergy to blood products
3. Patients diagnosed with abnormal coagulation function
4. Patients diagnosed with uterine malformation
5. Patients undergoing Preimplantation Genetic Testing
6. Patients diagnosed with hydrosalpinx
7. Patients diagnosed with infectious diseases
8. Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy
9. Prior personal history of stem cell clinical trail or other clinical trails
10. Unwilling to comply with study protocol
11. Patients identified with high risk for stem cell injection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hAMSCs injection; hAMSCs were injected via venous in the dorsum of hand.	Other: stem cells; hAMSCs injection via venous in the dorsum of hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability after hAMSCs injection.	Safety and tolerability assessed by Adverse Events and serious during injection and adverse events (SAEs) after injection assessed by long term follow-up .	Up to 12 months after first hAMSCs injection
The ratio of transplantable embryo in DOR patients after hAMSCs injection.	The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection.	Up to 12 months after first hAMSCs injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian function in DOR patients after hAMSCs injection.	Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level, Luteinizing Hormone (LH)serum level on menstrual day 2/3 will be evaluated after injection. The number of antral follicles will be recorded by transvaginal ultrasound scan.	Up to 12 months after first hAMSCs injection
Outcomes of IVF in DOR patients after hAMSCs injection.	The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate, after hAMSCs injection.	Up to 12 months after first hAMSCs injection

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Jiayin Liu, Doctor, First Affiliated Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Diminished ovarian response, human Amniotic Mesenchymal Stem Cells, Cell therapy
• Other Study ID Numbers: 2019-SCR-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No