Clinical trial NCT06951074: Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes
Official title: Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Stem Cells
Type 1 Diabetes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
timeFrame: 1 year
measure: Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
timeFrame: 1 year
measure: Insulin producing mesenchymal stem cells efficacy in insulin production in vivo
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children Hospital Eldemerdash
Study officials:
affiliation: Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams University
name: Rasha S Elmetwally, A. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of pediatrics, Faculty of Medicine, Ain Shams University
name: Randa M Matter, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.