Status:
UNKNOWN
Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients
Lead Sponsor:
Royan Institute
Collaborating Sponsors:
Tehran University of Medical Sciences
Iranian Stem Cell Council
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-40 years
Phase:
PHASE1
PHASE2
Brief Summary
Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulat...
Detailed Description
Diabetes is an autoimmune disease which is mainly caused by an immune reaction to beta cells in the pancreas. Today, insulin injection is a routine treatment for diabetes. Although injected insulin ma...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Type 1 diabetes detection in less than 6 weeks
- Diabetes diagnosis according to American Diabetes Association (ADA)
- Presence of Antibodies against pancreatic beta cells
- Fasting C-peptide ≥ 0.3 ng/ml
- Exclusion Criteria
- Pregnancy or breastfeeding
- Cancer
- Any acute or severe disease (According to physicians' diagnosis: such as cardiac, pulmonary, hepatic, kidney, mental, … diseases)
- Positive results for: Human Immunodeficiency Virus (HIV), Human T-Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Cytomegalovirus (CMV)
- Immune deficient or hyper aesthesia
- History of severe ketoacidosis
Exclusion
Key Trial Info
Start Date :
July 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04078308
Start Date
July 6 2015
End Date
April 1 2020
Last Update
September 6 2019
Active Locations (1)
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1
Royan Institute
Tehran, Iran, 16635-148