Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
Overview
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
Full Title of Study: “Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: September 30, 2022
Interventions
- Other: Observational
- Product in a Institute of Bio-Stem Cell rehabilitation UAB – sponsored clinical trial who agree to participate in this study
Clinical Trial Outcome Measures
Primary Measures
- Antral follicular count (AFC) serum levels
- Time Frame: 2 years
- Antral follicular count (AFC) <5-7 follicles
- anti-Müllerian hormone (AMH) serum levels
- Time Frame: 2 years
- AMH <0.5-1.1 ng/ml
Secondary Measures
- Regular menstruation and/or pregnancy
- Time Frame: 2 years
- regular menstruation for 5 months and\or pregnancy
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 40 Years
Investigator Details
- Lead Sponsor
- Ukraine Association of Biobank
- Provider of Information About this Clinical Study
- Sponsor
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