Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy (UB-OVF)

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

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 Overview

• Status: Completed
• Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Ukraine
  • Kharkiv, Ukraine
    • Institute of Bio-Stem Cell Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with premature ovarian insufficiency (Diagnostic criteria of ESHRE) who have been treated with ex vivo gene therapy product in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antral follicular count (AFC) serum levels	Antral follicular count (AFC) <5-7 follicles	2 years
anti-Müllerian hormone (AMH) serum levels	AMH <0.5-1.1 ng/ml	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regular menstruation and/or pregnancy	regular menstruation for 5 months and\or pregnancy	2 years

Collaborators and Investigators

• Sponsor: Ukraine Association of Biobank

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Premature ovarian failure; mesenchymal stem cell; stem cell therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: UAB1220-2

Drug and device information, study documents

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