NCT04642911

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Ukraine Association of Biobank · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Diabete Type 2
• Mesenchymal Stem Cell

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-09-01
• Completion: 2030-10-10
• First posted: 2020-11-24
• Last updated: 2021-10-15

Locations

1 site across 1 country: Ukraine