Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes

NCT ID: NCT06951074

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-09-01

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.

Conditions

Stem Cells; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1a IPSC transplant in portal circulation

Insulin producing stem cells injection in portal circulation

Group Type: EXPERIMENTAL

Insulin producing stem cells infusion

Intervention Type: 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 1b IPSC in peripheral systemic circulation

Insulin producing stem cells injection in peripheral systemic circulation

Group Type: EXPERIMENTAL

Insulin producing stem cells infusion

Intervention Type: 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

Interventions

Insulin 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Type 1 diabetes

Exclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasha S Elmetwally, A. Prof

Role: PRINCIPAL_INVESTIGATOR

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

Randa M Matter, Prof

Role: STUDY_DIRECTOR

Professor of pediatrics, Faculty of Medicine, Ain Shams University

Locations

Children Hospital Eldemerdash

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rasha S Elmetwally, MD

Role: CONTACT

dr.rashaeladawy@med.asu.edu.eg

20201092143033 ext. 02

Rasha S Eladawy, MD

Role: CONTACT

Rashaeladawy1@gmail.com

01092143033 ext. 02

Facility Contacts

Rasha Eladawy Shaaban Elmetwally, MD

Role: primary

dr.rashaeladawy@med.asu.edu.eg

20201092143033

References

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.

Reference Type: BACKGROUND

PMID: 39710778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30777564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36042996 (View on PubMed)

Other Identifiers

AinShamsPedDiabetes

Identifier Type: -

Identifier Source: org_study_id