Clinical Trial

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

Study acronym: AUB001
Active, Not Recruiting
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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-11-18.
Status change: Enrolling by Invitation → Active, Not Recruiting 2021-10-13
Trial Details
NCT Number NCT04642911
Lead Sponsor Ukraine Association of Biobank
Conditions Diabete Type 2, Mesenchymal Stem Cell
Enrollment 91 participants
Start Date 2020-10-15
Primary Completion 2021-09-01 (estimated)
Study Completion 2030-10-10 (estimated)
Updated on ClinicalTrials.gov 2021-10-15