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Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy
Sponsor: Ukraine Association of Biobank
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
Official title: Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
91
Start Date
2020-10-15
Completion Date
2030-10-10
Last Updated
2021-10-15
Healthy Volunteers
No
Conditions
Interventions
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 (1)
Institute of Bio-Stem Cell Rehabilitation
Kharkiv, Ukraine