Transplantation of hAMSCs for Woman With DOR

NCT04706312 | Unknown Phase 1

• 1 other identifier: 2019-SCR-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diminished Ovarian Response

Keywords

Diminished ovarian response, human Amniotic Mesenchymal Stem Cells, Cell therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ovarian function in DOR patients after hAMSCs injection.

  Up to 12 months after first hAMSCs injection

• Outcomes of IVF in DOR patients after hAMSCs injection.

  Up to 12 months after first hAMSCs injection

Study Arms (1)

hAMSCs injection

EXPERIMENTAL

hAMSCs were injected via venous in the dorsum of hand.

Other: stem cells

Interventions

stem cells OTHER

hAMSCs injection via venous in the dorsum of hand

hAMSCs injection

Eligibility Criteria

• Age: 35 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Willing to sign the Informed Consent Form.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Study Officials

• Jiayin Liu, Doctor

  First Affiliated Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Xiang Ma, Doctor

CONTACT

+8618001581878; sxmaxiang@126.com

Lianju Qin, Doctor

CONTACT

+86 18012923584; ljqin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 12, 2021
• Study Start: April 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2024
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)