Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Stem Cells
• Intervention / Treatment: Biological: Insulin producing stem cells infusion

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Rasha S Elmetwally, MD; Phone Number: 02 20201092143033; Email: dr.rashaeladawy@med.asu.edu.eg
• Study Contact Backup: Name: Rasha S Eladawy, MD; Phone Number: 02 01092143033; Email: Rashaeladawy1@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Children Hospital Eldemerdash
    • Contact: Rasha Eladawy Shaaban Elmetwally, MD; Phone Number: 20201092143033; Email: dr.rashaeladawy@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1a IPSC transplant in portal circulation; Insulin producing stem cells injection in portal circulation	Biological: Insulin producing stem cells infusion; Liposuction of the anterior abdominal subcutaneous fat layer of participant; Characterization and Identification of mesenchymal stem cells; Differentiation of mesenchymal stem cells into insulin producing stem cells; In vitro detection of Insulin and c-peptide in differentiated MSC (Confirmatory tests for the insulin producing cells); In vitro Insulin and c-peptide release detection in differentiated MSC in response to increasing glucose concentrations Differentiated MSCs injection in human subjects; Followup
Experimental: group 1b IPSC in peripheral systemic circulation; Insulin producing stem cells injection in peripheral systemic circulation	Biological: Insulin producing stem cells infusion; Liposuction of the anterior abdominal subcutaneous fat layer of participant; Characterization and Identification of mesenchymal stem cells; Differentiation of mesenchymal stem cells into insulin producing stem cells; In vitro detection of Insulin and c-peptide in differentiated MSC (Confirmatory tests for the insulin producing cells); In vitro Insulin and c-peptide release detection in differentiated MSC in response to increasing glucose concentrations Differentiated MSCs injection in human subjects; Followup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rasha S Elmetwally, A. Prof, Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams University; Study Director: Randa M Matter, Prof, Professor of pediatrics, Faculty of Medicine, Ain Shams University

Publications and helpful links

General Publications

• Abou Zaki R, El-Osta A. Advancing type 1 diabetes therapy: autologous islet transplant breakthrough. Signal Transduct Target Ther. 2024 Dec 23;9(1):366. doi: 10.1038/s41392-024-02090-x. No abstract available.
• Ulyanova O, Askarov M, Kozina L, Karibekov T, Shaimardanova G, Zhakupova A, Danilova D, Serebrennikova D. Autologous Mesenchymal Stem Cell Transplant in Patients with Type 1 Diabetes Mellitus. Exp Clin Transplant. 2019 Jan;17(Suppl 1):236-238. doi: 10.6002/ect.MESOT2018.P100.
• Jayasinghe M, Prathiraja O, Perera PB, Jena R, Silva MS, Weerawarna PSH, Singhal M, Kayani AMA, Karnakoti S, Jain S. The Role of Mesenchymal Stem Cells in the Treatment of Type 1 Diabetes. Cureus. 2022 Jul 27;14(7):e27337. doi: 10.7759/cureus.27337. eCollection 2022 Jul.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin
• Other Study ID Numbers: AinShamsPedDiabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No