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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Primary Ovarian Insufficiency Premature Ovarian Failure

Keywords

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Premature ovarian failure stem cell therapy mesenchymal stem cell

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Observational

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Bio-Stem Cell Rehabilitation

Kharkiv, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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UAB1220-2

Identifier Type: -

Identifier Source: org_study_id