Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy (AUB001)

Ukraine Association of Biobank

Status: Active, not recruiting

Conditions: Mesenchymal Stem Cell; Diabete Type 2

Treatments: Other: Long term follow up

Study type: Observational

Funder types: Other

Identifiers

NCT04642911

UAB00171120-1

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

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