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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-06

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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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 maintains blood glucose, this method cannot result in physiologic reaction to blood glucose changes. Moreover, patients are encountered with diabetes complications like neuropathy, nephropathy, visual and cardiovascular problems, and hypoglycemic unawareness. Therefore, based on previous studies, a treatment option that leads to pancreatic beta cell restoration and inhibits the immune response to these cells could be a hopeful clinical choice. In this clinical trial, autologous bone marrow-derived mesenchymal stem cells will be used for immune response modulation and improving regeneration. Hence, based on inclusion and exclusion criteria, 20 patients with type-1 diabetes will be selected and after clarifying the procedure and fulfilling the agreement to participate in this trial, they will be sorted in two groups. Bone marrow is aspirated from patients bone and after isolation of Mesenchymal stem cells and characterization of these cells, patients in case group will be intravenously injected by 1 million autologous mesenchymal stem cells per kg of patient's body weight in each dose in week 0 and 3, whereas the control group receives a placebo. Then patients will be followed up for 1 year. During this time, different parameters would be evaluated in weeks 1, 2,4, and Months 2,3,6,9 and 12. Laboratory screenings will be done during this period to evaluate the safety and efficacy of this treatment.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mesenchymal Stem Cells Transplantation

The patients with Type 1 Diabetes, who will receive Intravenous injection of autologous bone-marrow derived mesenchymal stem cells

Group Type EXPERIMENTAL

Intravenous Injection of autologous mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Placebo

The patients with Type 1 Diabetes, who will receive intravenous injection of normal saline (sodium chloride 0.9%)

Group Type PLACEBO_COMPARATOR

Intravenous injection of placebo

Intervention Type OTHER

Intravenous injection of normal saline (sodium chloride 0.9%)

Interventions

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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

Intervention Type BIOLOGICAL

Intravenous injection of placebo

Intravenous injection of normal saline (sodium chloride 0.9%)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdolhossein Shahverdi, PhD

Role: STUDY_CHAIR

Royan Institute, ACECR, Tehran, I.R. Iran

Hossein Baharvand, PhD

Role: STUDY_DIRECTOR

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

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences, Tehran, I.R. Iran

Ensiyeh Hajizadeh saffar, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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