Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy
Active, not recruiting
- Conditions
- Mesenchymal Stem CellDiabete Type 2
- Registration Number
- NCT04642911
- Lead Sponsor
- Ukraine Association of Biobank
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 91
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Bio-Stem Cell Rehabilitation
🇺🇦Kharkov, Ukraine