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Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

ConditionsStem CellsType 1 Diabetes
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15-18
SponsorAin Shams University

About this trial

Type 1 Diabetes is a chronic autoimmune disease. It results from autoimmune destruction of pancreatic Beta cells leading to absolute insulin insufficiency. The establishment of pluripotent like human stem cells derived from adipose tissue derived mesenchymal cell origin have introduced a new potential source for cell therapy in type 1 diabetic patients, especially in light of recent successes in producing glucose-sensitive insulin secreting cells and this will be the scope of this study. In the last decade, human clinical trials of introducing insulin producing stem cells from various origins were approved and conducted.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type 1 diabetes

Disqualifiers

patients with other autoimmune diseases

patients with micro or macro vascular complications

patients with other chronic diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Insulin producing stem cells infusion

    Biological/Vaccine

    1. Liposuction of the anterior abdominal subcutaneous fat layer of participant 2. Characterization and Identification of mesenchymal stem cells 3. Differentiation of mesenchymal stem cells into insulin producing stem cells 4. In vitro detection of Insulin and c-peptide in differentiated MSC (Confirmatory tests for the insulin producing cells) 5. In vitro Insulin and c-peptide release detection in differentiated MSC in response to increasing glucose concentrations Differentiated MSCs injection in human subjects 6. Followup

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: group 1a IPSC transplant in portal circulationExperimental treatment 1 intervention
Group B: group 1b IPSC in peripheral systemic circulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Insulin producing mesenchymal stem cells efficacy in insulin production in vitro

Assessment of the percentage of mature insulin and c peptide production in insulin producing stem cells.

Time frame
1 year
2

Insulin producing mesenchymal stem cells efficacy in insulin production in vitro

Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.

Time frame
1 year
3

Insulin producing mesenchymal stem cells efficacy in insulin production in vivo

Participants glycemic control will be assesed before and after insulin producing stem cells injection.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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