Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06951074

Insulin Producing Stem Cell Transplantation Clinical Trial in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stem Cells Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children Hospital Eldemerdash

Cairo, Egypt

Location status: Recruiting

Location contact

Rasha Eladawy Shaaban Elmetwally, MD

CONTACT

[email protected]

20201092143033

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes

Exclusion criteria

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

Treatment and study plan

Insulin producing stem cells infusion

Biological
  • 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

Primary outcomes

  1. Insulin producing mesenchymal stem cells efficacy in insulin production in vitro

    Time frame: 1 year

    Assessment of the percentage of mature insulin and c peptide production in insulin producing stem cells.

  2. Insulin producing mesenchymal stem cells efficacy in insulin production in vitro

    Time frame: 1 year

    Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.

  3. Insulin producing mesenchymal stem cells efficacy in insulin production in vivo

    Time frame: 1 year

    Participants glycemic control will be assesed before and after insulin producing stem cells injection.

Study contacts

Contact information is provided by the study sponsor or research team.

Rasha S Eladawy, MD

CONTACT

[email protected]

01092143033 ext. 02

Rasha S Elmetwally, MD

CONTACT

[email protected]

20201092143033 ext. 02

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.