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