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

Type 1 Diabetes Stem Cells

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether transplanting insulin-producing stem cells can help people with type 1 diabetes produce their own insulin again. In type 1 diabetes, the immune system destroys the cells in the pancreas that make insulin, so this therapy aims to restore that function using stem cell technology. **You may be eligible if...** - You have been diagnosed with type 1 diabetes **You may NOT be eligible if...** - You have other autoimmune diseases - You have complications of diabetes affecting small or large blood vessels (such as kidney disease, nerve damage, eye disease, or heart disease) - You have other significant chronic medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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