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NCT04642911 Clinical Trial

Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy

Diabete Type 2 Clinical Trial

— AUB001  

Official title:
Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04642911
Other study ID # UAB00171120-1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 15, 2020
Est. completion date October 10, 2030

Study information
Verified date October 2021
Source Ukraine Association of Biobank
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion. No investigation drug product will be administered in the study

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 91
Est. completion date October 10, 2030
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Treated with gene therapy of diabetes 2 type in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study - Able to comply with study requirements - Provision of written informed consent for this study by subjects or as applicable subject legal/parent guardian Exclusion Criteria: - There are no exclusion criteria for this study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Long term follow up
Undergo long term follow up, including copy number measurement safety evaluations diseases specific product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study

Locations
Country Name City State
Ukraine Institute of Bio-Stem Cell Rehabilitation Kharkov

Sponsors (1)
Lead Sponsor Collaborator
Ukraine Association of Biobank

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival of subject with diabetes 2 type with gene therapy drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study 10 years post-drug product infusion
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