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Trial record 30 of 339 for:    C-peptide | "Diabetes Mellitus, Insulin-Dependent"

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT04061746
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hongjun Wang, Medical University of South Carolina

Brief Summary:
The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: Mesenchymal Stem Cells (MSCs) Other: Placebo Infusion (Plasmalyte A with 0.5% human serum albumin) Phase 1

Detailed Description:

This study seeks to find and enroll participants with new onset Type 1 diabetes (T1D) within 3 months of the first dose of insulin. T1D is an autoimmune disease in which T cells attack and destroy insulin-secreting pancreatic β cells leading to insulin deficiency and hyperglycemia in patients. Life-long insulin therapy is the major treatment option. However, insulin therapy is not a cure and a safer and more effective therapy is needed.

Mesenchymal Stromal Cells (MSCs) have emerged as a novel biopharmaceutical approach for many disorders. MSCs are a cellular product that can be derived from a patient's own body (autologous) or from a donor (allogeneic). This study will obtain MSCs from umbilical cords at the time of delivery from normal women who have been extensively screened for infectious diseases. These cells produced at the MUSC Center for Cellular therapy will be used within 3 passages after collection.

Evidence from animal models and clinical trials suggests that MSC infusion suppresses autoimmune and inflammatory diseases such as T1D. One clear message from these trials is that MSCs are effective at suppressing autoimmunity and seem generally safe. This study will measure safety and efficacy of MSCs over the course of 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Group A Treatment
2.5 x 10^6 MSC per kg will be infused intravenously on Day 1
Biological: Mesenchymal Stem Cells (MSCs)
Patients in Group A will receive a single MSCs infusion

Placebo Comparator: Group B Placebo
Plasmalyte with 0.5% Human Serum Albumin will be infused intravenously on Day 1
Other: Placebo Infusion (Plasmalyte A with 0.5% human serum albumin)
Patients in Group B will receive a single infusion of placebo (Plasmalyte A with 0.5% human serum albumin)




Primary Outcome Measures :
  1. 12 month Change in C-peptide area under the curve after a 2-hour MMTT [ Time Frame: 1 year (plus or minus 30 days) after infusion ]
    Change in beta cell function


Secondary Outcome Measures :
  1. 6 Month Change in C-Peptide area under the curve after a 2-hour MMTT [ Time Frame: 6 months (plus or minus 14 days) after infusion ]
    Change in beta cell function

  2. 6 Month peak C-peptide after a 2-hour MMTT [ Time Frame: 6 months (plus or minus 14 days) after infusion ]
    Change in beta cell function

  3. 1 year peak C-peptide after a 2-hour MMTT [ Time Frame: 1 year (plus or minus 30 days) after infusion ]
    Change in beta cell function

  4. Change in 24-hour insulin dose per kilogram between baseline and 1 year measurements [ Time Frame: 1 year (plus or minus 30 days) after infusion ]
    Change in beta cell function


Other Outcome Measures:
  1. Fasting and postprandial blood glucose levels after MSC infusion [ Time Frame: 0 - 72 Hours ]
    Change in beta cell function

  2. Changes in basal C-peptide and hemoglobin A1c [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Change in beta cell function

  3. Change in serum glucagon levels [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Change in alpha cell function

  4. Insulin secretion rate [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Change in beta cell function

  5. Changes in islet autoanitbodies [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Change in autoantibody presence or titer

  6. Change in beta cell death measurements [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action

  7. Change in blood T-reg number and function [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action

  8. Change in autoantigen specific T-cell response [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action

  9. Change in blood autoreactive B cell number, B cell survival, and function [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action

  10. Changes in mRNA expression in peripheral blood mononuclear cells after treatment [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action

  11. Changes in serum cytokine levels after treatment [ Time Frame: Over the course of 1 year (0, 1, 3, 6, 12 months) ]
    Determination of the mechanism of action



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A new diagnosis of T1D based on the ADA criteria within 3 months of randomization.
  • Male and female between the ages of 12 and 30
  • Mentally stable and able to comply with the procedures of the study protocol
  • Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies
  • At screening, patients must have residual β cell function with a stimulated peak C-peptide >0.2 nmol/l during a 2 hour MMTT
  • Must be willing to comply with "intensive diabetes management" (* See diabetes management at MUSC below) as directed by the participant's clinician with the goal of maintaining blood glucose as close to normal as possible
  • Subject must be willing to comply with the schedule of study visits and protocol requirements
  • Subject with normal laboratory values of: White blood cell counts: between 4,500 to 11,000 per microliter; Platelet counts: 140,000 to 450,000 platelets per microliter of blood; Serum creatinine range is 0.6-1.3 mg/dL, Hepatic function: ALT 5 to 55 units per liter (U/L), AST 5 to 48 U/L.

Exclusion criteria:

  • Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review.
  • Body Mass Index < 14 or >35
  • Presence of malignancy
  • Subject has abnormally high lipid levels that exceeds > 3 times the upper limit of normal for LDL cholesterol or triglycerides
  • Subject has blood pressure greater than 160 mmHg systolic or 100 mmHg diastolic at time of consent
  • Subject is being treated for severe active infection of any type
  • A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
  • Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder)
  • Subjects with HgbA1c >12%, and/or fasting blood glucose >270 mg/dL and/or frequent episodes of hypoglycemia (>2 episodes per week of blood glucose levels <60 mg/dL).

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): NCT04061746


Contacts
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Contact: Meghan Schneider 843-792-2813 schneidm@musc.edu
Contact: Danielle Woodford, MS 843-792-6280 woodfordd@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Meghan Schneider    843-792-2813    schneidm@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Hongjun Wang, PhD Medical University of South Carolina

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Responsible Party: Hongjun Wang, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04061746     History of Changes
Other Study ID Numbers: 00085542
R01DK118529-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongjun Wang, Medical University of South Carolina:
mesenchymal stem cells
diabetes
autoantibodies
C-peptide
Type 1 diabetes mellitus
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
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions