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A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure

NCT02912104 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-01

No results posted yet for this study

Summary

This project will clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian failure (POF) patients and provide a new therapeutic method for patients with infertility.

Conditions

  • Primary Ovarian Insufficiency
  • Premature Ovarian Failure
  • Infertility

Interventions

BIOLOGICAL

human amniotic epithelial cells (hAECs) transplantation

hAECs are prepared and cultured using GMP(Good Manufacturing Practice, GMP) rules, 3×10\^7 hAECs in 4.5ml is separately injected into ovarian tissue by bilateral ovarian artery infusion.

Sponsors & Collaborators

  • Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

    collaborator INDUSTRY

  • International Peace Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • Dongmei Lai, M.D. · The center of Laboratory, The international peace Maternity and child health Hospital,School of Medicine, Shanghai Jiaotong University, Shanghai,China,200030

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2022-01-05
Completion
2023-01-05

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912104 on ClinicalTrials.gov