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

NCT04642911 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2021-10-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ukraine Association of Biobank

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-09-01
Completion
2030-10-10

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04642911 on ClinicalTrials.gov