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

NCT04642911 | Active Not Recruiting

• 1 other identifier: UAB00171120-1
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  10 years post-drug product infusion

Interventions

Long term follow up OTHER

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

Also known as: LONG TERM, FOLLOW UP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Ukraine Association of Biobank: lead

Study Sites (1)

Institute of Bio-Stem Cell Rehabilitation

Kharkiv, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: October 15, 2020
• Primary Completion: September 1, 2021
• Study Completion (Estimated): October 10, 2030
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

UA (1)