RecruitingPhase 2Phase 3NCT06951074

Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes


Sponsor

Ain Shams University

Enrollment

20 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 15 YearsMax Age: 18 Years

Inclusion Criteria1

  • Type 1 diabetes

Exclusion Criteria3

  • patients with other autoimmune diseases
  • patients with micro or macro vascular complications
  • patients with other chronic diseases

Interventions

BIOLOGICALInsulin producing stem cells infusion

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


Locations(1)

Children Hospital Eldemerdash

Cairo, Egypt

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NCT06951074


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