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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04675970

Acronym

UB-OVF

Enrollment

Registered

2020-12-19

Start date

2020-09-01

Completion date

2025-09-30

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Failure, Primary Ovarian Insufficiency

Keywords

Premature ovarian failure, stem cell therapy, mesenchymal stem cell

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

Interventions

OTHERObservational

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Antral follicular count (AFC) serum levels	2 years	Antral follicular count (AFC) \<5-7 follicles
anti-Müllerian hormone (AMH) serum levels	2 years	AMH \<0.5-1.1 ng/ml

Secondary

Measure	Time frame	Description
Regular menstruation and/or pregnancy	2 years	regular menstruation for 5 months and\\or pregnancy

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026