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

Premature Ovarian Failure Clinical Trial

— UB-OVF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04675970
• Other study ID #: UAB1220-2
• Status: Active, not recruiting
• Start date: September 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Ukraine Association of Biobank
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Other:
• Observational
Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study

Locations

Country	Name	City	State
Ukraine	Institute of Bio-Stem Cell Rehabilitation	Kharkov

Sponsors (1)

Lead Sponsor	Collaborator
Ukraine Association of Biobank

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicular count (AFC) serum levels	Antral follicular count (AFC) <5-7 follicles	2 years
Primary	anti-Müllerian hormone (AMH) serum levels	AMH <0.5-1.1 ng/ml	2 years
Secondary	Regular menstruation and/or pregnancy	regular menstruation for 5 months and\or pregnancy	2 years