UB-OVF: Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

• Sponsor: Ukraine Association of Biobank (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04675970
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Anticipated Duration (Months): 24.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Ovarian Insufficiency; Premature Ovarian Failure	Other: Observational

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Outcome Measures

Primary Outcome Measures

1. Antral follicular count (AFC) serum levels [2 years]

   Antral follicular count (AFC) <5-7 follicles

2. anti-Müllerian hormone (AMH) serum levels [2 years]

   AMH <0.5-1.1 ng/ml

Secondary Outcome Measures

1. Regular menstruation and/or pregnancy [2 years]

   regular menstruation for 5 months and\or pregnancy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Bio-Stem Cell Rehabilitation	Kharkov		Ukraine

Sponsors and Collaborators

• Ukraine Association of Biobank

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ukraine Association of Biobank
• ClinicalTrials.gov Identifier: NCT04675970
• Other Study ID Numbers: UAB1220-2
• First Posted: Dec 19, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ukraine Association of Biobank: Premature ovarian failure; stem cell therapy; mesenchymal stem cell
• Additional relevant MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature

Study Results

No Results Posted as of May 18, 2022