NCT04642911Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2021
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 91 (actual)
- First submitted
- 18 Nov 2020
- Start date
- 15 Oct 2020
- Primary completion date
- 1 Sept 2021
- Lead sponsor
- Ukraine Association of Biobank
- Diseases
- Type 2 diabetes
- NCT number
- NCT04642911
What you commit to
- Study type: Observational
- Participants enrolled: 91
- From 15 Oct 2020 to the primary completion date, 1 Sept 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are no exclusion criteria for this study
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Bio-Stem Cell Rehabilitation Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.