Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients

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 modulation and improving regeneration. Study design and method: In a Triple blinded randomized placebo-controlled phase I/II clinical trial, 20 patients with newly diagnosed type-1 diabetes who would be visited in Children's Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group and the placebo group. Participants: Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. Interventions: Intravascular transplantation of autologous mesenchymal stem cells in the case group; placebo injection in the control group. Outcome variables: safety and efficacy.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Insulin-Dependent

Interventions

BIOLOGICAL

Intravenous Injection of autologous mesenchymal stem cells

Intravenous injection 1 millions of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) per kg of patient's body weight in each dose, weeks 0 \& 3

OTHER

Intravenous injection of placebo

Intravenous injection of normal saline (sodium chloride 0.9%)

Sponsors & Collaborators

• Tehran University of Medical Sciences

  collaborator OTHER

• Iranian Stem Cell Council

  collaborator UNKNOWN

• Royan Institute

  lead OTHER_GOV

Principal Investigators

• Abdolhossein Shahverdi, PhD · Royan Institute, ACECR, Tehran, I.R. Iran

• Hossein Baharvand, PhD · Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, ACECR, Tehran, I.R. Iran

• Ali Rabbani, MD · Tehran University of Medical Sciences, Tehran, I.R. Iran

• Ensiyeh Hajizadeh saffar, MD,PhD · Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, ACECR, Tehran, I.R. Iran

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-06

Primary Completion

2019-09-26

Completion

2020-04-01

Countries

• Iran

Study Locations