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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2030-10-10

Brief Summary

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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

Detailed Description

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Conditions

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Diabete Type 2 Mesenchymal Stem Cell

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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LONG TERM FOLLOW UP

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Bio-Stem Cell Rehabilitation

Kharkiv, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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UAB00171120-1

Identifier Type: -

Identifier Source: org_study_id