NCT02912104

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
3.7 years until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

September 6, 2016

Last Update Submit

February 27, 2023

Conditions

Primary Ovarian InsufficiencyPremature Ovarian FailureInfertility

Keywords

primary ovarian insufficiencypremature ovarian failureInfertilityhuman amniotic epithelial cells transplantation

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability assessed by Adverse Events

    Proportion of patients with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI，such as acute allergic reaction, ectopic mass formation related to treatment)

    150 days

Secondary Outcomes (8)

  • Change from baseline in bilateral ovarian volume

    150 days

  • Change from baseline in number of antral follicles (AFC)

    150 days

  • Change from baseline in Follicle-stimulating hormone (FSH) serum level

    150 days

  • Change from baseline in Luteinizing hormone (LH), Estradiol (E2), Testosterone (T), Prolactin (PRL) , Anti-müllerian hormone (AMH) serum level

    150 days

  • Menstruation resumption

    150 days

  • +3 more secondary outcomes

Study Arms (1)

hAECs transplantation

EXPERIMENTAL

To clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of POF patients

Biological: human amniotic epithelial cells (hAECs) transplantation

Interventions

human amniotic epithelial cells (hAECs) transplantationBIOLOGICAL

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.

Also known as: hAECs transplantation
hAECs transplantation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ≥18 and\<45 years old.
  • Female patients with documented diagnosis of POF: \<40 years old, at least 4 months of amenorrhea not due to pregnancy, two FSH levels above 40 IU/L, at least one month apart.
  • Not in other trial within 3 months prior to the start of this trial.
  • Willing to participate in this trial and to give informed consent/assent before any procedures are performed in this trial.

You may not qualify if:

  • History of, or evidence of current malignancy within the past 5 years.
  • Severe functional impairment of vital organs.
  • Abnormal karyotype.
  • Coagulation disorders.
  • Severe pelvic adhesions.
  • Uncontrolled acute or chronic gynecologic inflammation.
  • Congenital adrenal cortical hyperplasia.
  • Cushing's syndrome.
  • Thyroid dysfunction.
  • Pituitary adenoma.
  • Pituitary amenorrhea or Hypothalamic amenorrhea.
  • Thrombophlebitis, venous thrombosis or artery thrombosis.
  • History of Oophorocystectomy.
  • Currently pregnant or breast-feeding.
  • Currently receiving other treatment that might affect the efficacy and safety of stem cells.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (4)

  • Wang F, Wang L, Yao X, Lai D, Guo L. Human amniotic epithelial cells can differentiate into granulosa cells and restore folliculogenesis in a mouse model of chemotherapy-induced premature ovarian failure. Stem Cell Res Ther. 2013 Oct 14;4(5):124. doi: 10.1186/scrt335.

    PMID: 24406076RESULT

  • Zhang Q, Xu M, Yao X, Li T, Wang Q, Lai D. Human amniotic epithelial cells inhibit granulosa cell apoptosis induced by chemotherapy and restore the fertility. Stem Cell Res Ther. 2015 Aug 25;6(1):152. doi: 10.1186/s13287-015-0148-4.

    PMID: 26303743RESULT

  • Yao X, Guo Y, Wang Q, Xu M, Zhang Q, Li T, Lai D. The Paracrine Effect of Transplanted Human Amniotic Epithelial Cells on Ovarian Function Improvement in a Mouse Model of Chemotherapy-Induced Primary Ovarian Insufficiency. Stem Cells Int. 2016;2016:4148923. doi: 10.1155/2016/4148923. Epub 2015 Nov 9.

    PMID: 26664408RESULT

  • Weng L, Wei L, Zhang Q, Sun T, Kuang X, Huang Q, Cao Y, Liu X, Wang Q, Guo Y, Sun J, Wang L, Tang H, Yang H, Chen Q, Zhang J, Wang B, Qian Z, Lai D. Safety and efficacy of allogenic human amniotic epithelial cells transplantation via ovarian artery in patients with premature ovarian failure: a single-arm, phase 1 clinical trial. EClinicalMedicine. 2024 Jul 30;74:102744. doi: 10.1016/j.eclinm.2024.102744. eCollection 2024 Aug.

    PMID: 39165278DERIVED

MeSH Terms

Conditions

Primary Ovarian InsufficiencyInfertility

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 23, 2016

Study Start

June 20, 2020

Primary Completion

January 5, 2022

Study Completion

January 5, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

The public can require the data and protocol from clinicaltrials.gov posted by investigator

Shared Documents
STUDY PROTOCOL
Time Frame
2 years
Access Criteria
public
More information

Locations

CN(1)