Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

NCT06951074 | Recruiting Phase 2 DMC

• 1 other identifier: AinShamsPedDiabetes
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cells; Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

group 1a IPSC transplant in portal circulation

EXPERIMENTAL

Insulin producing stem cells injection in portal circulation

Biological: Insulin producing stem cells infusion

group 1b IPSC in peripheral systemic circulation

EXPERIMENTAL

Insulin producing stem cells injection in peripheral systemic circulation

Biological: Insulin producing stem cells infusion

Interventions

Insulin producing stem cells infusion BIOLOGICAL

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

group 1a IPSC transplant in portal circulation; group 1b IPSC in peripheral systemic circulation

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 diabetes

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Children Hospital Eldemerdash

Cairo, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 39710778 BACKGROUND

• 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.

  PMID: 30777564 BACKGROUND

• 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.

  PMID: 36042996 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rasha S Elmetwally, A. Prof

  Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Randa M Matter, Prof

  Professor of pediatrics, Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Rasha S Elmetwally, MD

CONTACT

20201092143033; dr.rashaeladawy@med.asu.edu.eg

Rasha S Eladawy, MD

CONTACT

01092143033; Rashaeladawy1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty youth with T1D, aged 15 to 18 years will participate in this clinical trial. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines for Type 1 diabetes diagnosis (2024) will be used to confirm the diagnosis of Type 1 Diabetes. Patients' group will be subsequently separated into two subgroups 1a and 1b, each of which contain 10 patients. Group 1a will represent patients who will receive the insulin producing MScs through the portal circulation via Ultrasound guided portal vein injection. Group 1b will represent the patients who will receive the insulin producing MScs through the systemic circulation via peripheral cannulation. The Pediatrics and Adolescent Diabetic Clinic at Ain Shams University Hospital will be used to enroll T1D participants. Patients involved in the study will be admitted in the Pediatric Hospital (El-Demerdash)

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)