NCT04675970

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Ukraine Association of Biobank · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: —

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

Conditions

• Primary Ovarian Insufficiency
• Premature Ovarian Failure

Interventions

Type	Name	Description
OTHER	Observational	Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2020-12-19
• Last updated: 2025-12-22

Locations

1 site across 1 country: Ukraine