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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642911
Recruitment Status : Enrolling by invitation
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ukraine Association of Biobank

Study Description
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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


Condition or disease Intervention/treatment
Diabete Type 2 Mesenchymal Stem Cell Other: Long term follow up

Study Design
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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : October 10, 2030
Estimated Study Completion Date : October 10, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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
    Other Names:
    • LONG TERM
    • FOLLOW UP

Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 10 years post-drug product infusion ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642911


Locations
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Ukraine
Institute of Bio-Stem Cell Rehabilitation
Kharkov, Ukraine
Sponsors and Collaborators
Ukraine Association of Biobank
More Information
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Responsible Party: Ukraine Association of Biobank
ClinicalTrials.gov Identifier: NCT04642911    
Other Study ID Numbers: UAB00171120-1
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases