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IRCT20210925052566N1 IRCT 2022-01-23 Endocrinology and Metabolism Research Institute Transplantation of stem cells for the treatment of type 1 diabetes. Transplantation of allogenic mesenchymal stem cells (MSCs) derived from placenta and adipose tissue for the treatment of type 1 diabetes mellitus (T1DM): a clinical trial, phase 1 and 2. 2022-05-22 anticipated 30 Complete https://irct.ir/trial/58920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method with block sizes of 3 will be use to randomize individuals using sealedenvelope online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Allocation concealment will be carry out, Blinding description: After randomization by sealedenvelope online software, the codes which generated by software are placed on stem cell or placebo bags by the stem cell production laboratory (stem cell and placebo bags are similar), both participants and researchers do not know the codes and are unaware of the study groups. The codes will be decrypted only after the end of the study or when serious complications occur. 1-2 Type 1 diabetes mellitus (T1DM). Intervention 1: Intervention group-1: In this group, patients will be given allogeneic adipose tissue derived MSCs (single intravenous [IV] infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Intervention 2: Intervention group-2: In this group, patients will be given allogeneic placenta tissue derived MSCs (single IV infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Intervention 3: Control group: 100 mL of normal saline (single IV infusion). Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Starting 6 months after publication To whom: Only available for people working in academic institutions Conditions: The data can be analyzed after obtaining permission from the principal investigator Where to obtain: Email to principal investigator m_sajadi@tums.ac.ir How to obtain: Email to primary investigator Comments:
public Sayed Mahmoud Sajjadi Jazi
Endocrinology and Metabolism Department, Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0038 m_sajadi@tums.ac.ir Tehran University of Medical Sciences scientific Sayed Mahmoud Sajjadi Jazi
Endocrinology and Metabolism Department, Dr. Shariati Hospital, Jalal-AL-Ahmad Hwy., North Kargar St.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8822 0038 m_sajadi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All adults (≥ 18 year) with T1DM which diagnosis less than 1 year from the onset of diabetes Have at least one T1DM related autoantibody 18 years no limit Both Inability to fill informed consent Pregnancy in women Having any chronic complication of diabetes including nephropathy, retinopathy and vascular complications Having a serious infection or have a positive test for hepatitis B, hepatitis C or HIV Having other chronic comorbidities such as psychological, cardiovascular, renal, pulmonary, liver, hematologic and other serious autoimmune diseases (except T1DM or Hashimoto's disease) History of cancer History of diabetic ketoacidosis E10 Type 1 diabetes mellitus Treatment - Drugs Treatment - Drugs Placebo Intervention group-1: In this group, patients will be given allogeneic adipose tissue derived MSCs (single intravenous [IV] infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Intervention group-2: In this group, patients will be given allogeneic placenta tissue derived MSCs (single IV infusion of 1×10^6 cells/kg suspended in 100 mL of normal saline). Control group: 100 mL of normal saline (single IV infusion). Daily insulin requirement. Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention. Method of measurement: Total daily Insulin Requirement (in units of insulin). HbA1c. Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention. Method of measurement: Blood sample. Basal and stimulated C-peptide level. Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention. Method of measurement: Blood sample. Side effects. Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention. Method of measurement: History and physical examination. Endocrinology and Metabolism Research Institute Approved 2021-09-15 Ethics Committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)