Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

Phase 2

Recruiting

• Conditions: Stem Cells; Type 1 Diabetes
• Interventions: Biological: Insulin producing stem cells infusion

• Registration Number: NCT06951074
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Differentiation of stem cells from various sources to form insulin-producing cells (IPCS) provides a new and promising strategy to reconstitute pancreatic endocrine function. Studies recently developed a multistep differentiation technique for the differentiation of human embryonic stem cells to form pancreatic progenitors. At the end of in vitro differentiation approximately 5% of cells became insulin positive.

Mesenchymal stem cells (MSCs) can be derived from various sources. MSCs are undifferentiated cells with multilinear potential, known for their immunomodulatory and regenerative properties . The bone marrow, adipose tissue, umbilical cord, liver cells, and endometrium are among several tissues that are rich in MSCs. Of these, the bone marrow and adipose tissues offer distinct advantages in view of their availability and abundance and the extent of their documentation.

In this study the investigators aim to obtain autologous differentiated insulin producing mesenchymal stem cells (derived from adipose tissue) and their introduction in human subjects with type 1 diabetes. The current study will assess of the ability of the transplanted cells to produce insulin both in vitro and in vivo. Post- transplant glycemic control will be assessed with possible amelioration of the standard treatment of type 1 diabetes.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-05-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Type 1 diabetes

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1a IPSC transplant in portal circulation	Insulin producing stem cells infusion	Insulin producing stem cells injection in portal circulation
group 1b IPSC in peripheral systemic circulation	Insulin producing stem cells infusion	Insulin producing stem cells injection in peripheral systemic circulation

Primary Outcome Measures

Name	Time	Method
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro	1 year	Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.
Insulin producing mesenchymal stem cells efficacy in insulin production in vivo	1 year	Participants glycemic control will be assesed before and after insulin producing stem cells injection.

Trial Locations

Locations (1)

Children Hospital Eldemerdash; 🇪🇬 Cairo, Egypt