Stem Cells, Type 1 Diabetes
Conditions
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.
Interventions
BIOLOGICALInsulin 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes
Exclusion criteria
* patients with other autoimmune diseases * patients with micro or macro vascular complications * patients with other chronic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin producing mesenchymal stem cells efficacy in insulin production in vitro | 1 year | Assessment of the percentage of mature insulin and c peptide production in insulin producing stem cells. |
| Insulin producing mesenchymal stem cells efficacy in insulin production in vivo | 1 year | Participants glycemic control will be assesed before and after insulin producing stem cells injection. |
Countries
Egypt
Contacts
Primary ContactRasha S Elmetwally, MD
Backup ContactRasha S Eladawy, MD
Outcome results
None listed