Diabete Type 2, Mesenchymal Stem Cell
Conditions
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
Interventions
OTHERLong 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
Sponsors
Ukraine Association of Biobank
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Ukraine
Outcome results
None listed