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Trial record 23 of 7597 for:    stem cells

Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients (MSCTXT1DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078308
Recruitment Status : Active, not recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
Tehran University of Medical Sciences
Iranian Stem Cell Council
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Insulin-Dependent Biological: Intravenous Injection of autologous mesenchymal stem cells Other: Intravenous injection of placebo Phase 1 Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial to Examine the Safety and Efficacy of Transplantation of Mesenchymal Stem Cells in New-onset Type 1 Diabetes Patients
Actual Study Start Date : July 6, 2015
Estimated Primary Completion Date : September 26, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells Transplantation
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
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 Comparator: Placebo
The patients with Type 1 Diabetes, who will receive intravenous injection of normal saline (sodium chloride 0.9%)
Other: Intravenous injection of placebo
Intravenous injection of normal saline (sodium chloride 0.9%)




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 12 months after the first infusion ]
    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

  2. Change from baseline number of hypoglycemic Unawareness episodes at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Number of hypoglycemic unawareness episodes will be assessed by evaluating patients' blood glucose monitoring sheets


Secondary Outcome Measures :
  1. Change from Baseline Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline Fasting Blood Sugar (FBS)

  2. Change from Baseline C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing serum C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline serum C-peptide level

  3. Change from Baseline HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline HbA1C

  4. Change from Baseline 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline 2-hour postprandial blood glucose

  5. 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 [ Time Frame: 12 months after the first infusion ]
    Exogenous Insulin requirement of patients will be measured based on their daily insulin injection report sheets, total injected insulin units per day will be divided by patient's weight in order to be comparable between different patients.

  6. Change from baseline Lability Index (LI) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing 2 weeks of blood glucose report sheets, calculation is based on the changes in blood glucose levels over time

  7. Change from Baseline SF-36 Quality of life (QOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]

    Assessing change in patients' Quality of life by answering SF-36 questionnaire before transplantation and 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells; This questionnaire asks about general aspects of patients' life.

    The results would be reported as the total score and the scale range is from 0% to 100%. 0% is considered as worse condition and 100% is considered as the best condition.


  8. Change from Baseline Diabetes Specific Quality of life (DQOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]

    Assessing change in patients' Quality of life by answering Diabetes Specific Quality of Life (DQOL) questionnaire before transplantation and 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells; This questionnaire asks about different aspects of patients' life in relation to diabetes.

    The results would be reported as the total score and the scale range is from 0% to 100%. 0% is considered as worse condition and 100% is considered as the best condition.


  9. Changes from baseline Autoantibodies levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing patients Islet Cell Antibodies (ICA), Glutamic Acid Decarboxylase Antibodies (GADA), Insulinoma-Associated protein-2 Antibodies (IA-2A) levels after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells

  10. Changes from baseline serum cytokines levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells [ Time Frame: 12 months after the first infusion ]
    Assessing serum cytokines levels of patients after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078308


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 16635-148
Sponsors and Collaborators
Royan Institute
Tehran University of Medical Sciences
Iranian Stem Cell Council
Investigators
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Study Chair: Abdolhossein Shahverdi, PhD Royan Institute, ACECR, Tehran, I.R. Iran
Study Director: 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
Principal Investigator: 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

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT04078308     History of Changes
Other Study ID Numbers: RI-SCBT-94000019
IRCT2016070428786N1 ( Registry Identifier: Iranian Registry of Clinical Trials (IRCT) )
94000019 ( Other Grant/Funding Number: Royan Institute )
REP-441 ( Other Grant/Funding Number: Iranian Stem Cell Council, Vice-presidency for Science and Technology, Presidency of the Islamic Republic of Iran )
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royan Institute:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Cell Transplantation
Autologous Transplantation
Mesenchymal Stem Cell
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases