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

October 13, 2021 updated by: Ukraine Association of Biobank

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kharkov, Ukraine
        • Institute of Bio-Stem Cell Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject with diabetic 2 type who have treated with gene therapy in a drug product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 10 years post-drug product infusion
10 years post-drug product infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukraine Association of Biobank

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2020

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ANTICIPATED)

October 10, 2030

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB00171120-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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