- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675970
Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy (UB-OVF)
May 16, 2022 updated by: Ukraine Association of Biobank
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
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kharkov, Ukraine
- Institute of Bio-Stem Cell Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antral follicular count (AFC) serum levels
Time Frame: 2 years
|
Antral follicular count (AFC) <5-7 follicles
|
2 years
|
anti-Müllerian hormone (AMH) serum levels
Time Frame: 2 years
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AMH <0.5-1.1 ng/ml
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regular menstruation and/or pregnancy
Time Frame: 2 years
|
regular menstruation for 5 months and\or pregnancy
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2020
Primary Completion (ANTICIPATED)
September 30, 2022
Study Completion (ANTICIPATED)
September 30, 2022
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 (ACTUAL)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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