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Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes
NCT06951074 · Ain Shams University
In plain English
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Official title
Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
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.
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
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-04-01
Estimated completion: 2026-09-01
Last updated: 2025-04-30
Interventions
Biological: Insulin producing stem cells infusion
Primary outcomes
- • Insulin producing mesenchymal stem cells efficacy in insulin production in vitro (1 year)
- • Insulin producing mesenchymal stem cells efficacy in insulin production in vitro (1 year)
- • Insulin producing mesenchymal stem cells efficacy in insulin production in vivo (1 year)
Sponsor
Ain Shams University · other
Contacts & investigators
ContactRasha S Elmetwally, MD · contact · dr.rashaeladawy@med.asu.edu.eg · 20201092143033
ContactRasha S Eladawy, MD · contact · Rashaeladawy1@gmail.com · 01092143033
InvestigatorRasha S Elmetwally, A. Prof · principal_investigator, Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams University
InvestigatorRanda M Matter, Prof · study_director, Professor of pediatrics, Faculty of Medicine, Ain Shams University
All locations (1)
Children Hospital EldemerdashRecruiting
Cairo, Egypt