Skip to main content
Clinical Trials/NCT04675970
NCT04675970CompletedNot Applicable

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate

Ukraine Association of Biobank1 site in 1 country86 target enrollmentStarted: September 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
anti-Müllerian hormone (AMH) serum levels

Study Overview

Brief Summary

This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.
  • Diagnosed of premature ovarian insufficiency ESHRE:
  • Women age of 18 to 40 years
  • Have experienced 4 months of oligo/amenorrhea
  • Two serum follicle-stimulating hormone (FSH was >40 mIU/ml levels in the menopausal range, obtained at least a month apart
  • lower FSH levels ( 25 mIU/ml)
  • anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml)

Exclusion Criteria

  • There are no exclusion criteria for this study

Outcomes

Primary Outcomes

anti-Müllerian hormone (AMH) serum levels

Time Frame: 2 years

AMH \<0.5-1.1 ng/ml

Antral follicular count (AFC) serum levels

Time Frame: 2 years

Antral follicular count (AFC) \<5-7 follicles

Secondary Outcomes

  • Regular menstruation and/or pregnancy(2 years)

Investigators

Sponsor
Ukraine Association of Biobank
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Long Term Follow up Patients With... | Clinical Trial