NCT04078308

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

June 24, 2019

Last Update Submit

September 2, 2019

Conditions

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

Keywords

Diabetes MellitusDiabetes Mellitus, Type 1Cell TransplantationAutologous TransplantationMesenchymal Stem Cell

Outcome Measures

Primary Outcomes (2)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety will be assessed by evaluating patients based on CTCAE (v.5) to assess treatment-related adverse events after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • Change from baseline number of hypoglycemic Unawareness episodes at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    Number of hypoglycemic unawareness episodes will be assessed by evaluating patients' blood glucose monitoring sheets

    12 months after the first infusion

Secondary Outcomes (10)

  • Change from Baseline Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • Change from Baseline C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • Change from Baseline HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • Change from Baseline 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • Change from Baseline daily dose of exogenous insulin injected by patients (IU/kg/day) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

    12 months after the first infusion

  • +5 more secondary outcomes

Study Arms (2)

Mesenchymal Stem Cells Transplantation

EXPERIMENTAL

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

Biological: Intravenous Injection of autologous mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

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

Other: Intravenous injection of placebo

Interventions

Intravenous Injection of autologous mesenchymal stem cellsBIOLOGICAL

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

Mesenchymal Stem Cells Transplantation
Intravenous injection of placeboOTHER

Intravenous injection of normal saline (sodium chloride 0.9%)

Placebo

Eligibility Criteria

Age8 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, 16635-148, Iran

Location

Related Publications (1)

  • Izadi M, Sadr Hashemi Nejad A, Moazenchi M, Masoumi S, Rabbani A, Kompani F, Hedayati Asl AA, Abbasi Kakroodi F, Jaroughi N, Mohseni Meybodi MA, Setoodeh A, Abbasi F, Hosseini SE, Moeini Nia F, Salman Yazdi R, Navabi R, Hajizadeh-Saffar E, Baharvand H. Mesenchymal stem cell transplantation in newly diagnosed type-1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial. Stem Cell Res Ther. 2022 Jun 20;13(1):264. doi: 10.1186/s13287-022-02941-w.

    PMID: 35725652DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Abdolhossein Shahverdi, PhD

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

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Ali Rabbani, MD

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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

September 6, 2019

Study Start

July 6, 2015

Primary Completion

September 26, 2019

Study Completion

April 1, 2020

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)