Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01576328
First received: April 9, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.


Condition Intervention Phase
Type 2 Diabetes
Drug: Mesenchymal Precursor Cells (MPCs)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • Primary objective of the study is to assess the safety and tolerability of MPC therapy [ Time Frame: 116 Weeks ] [ Designated as safety issue: Yes ]

    Outcomes include the measurement of the following safety parameters:

    • Adverse events and serious adverse events(including hypoglycemia)
    • Vital signs (BP, HR, RR, O2 saturation)
    • Physical examinations
    • Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis)
    • Pulmonary function test
    • Electrocardiograms
    • Chest X-ray
    • Fundus oculi examination


Enrollment: 61
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
MPC dose 1 or Placebo
Drug: Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 1
Experimental: Cohort 2
MPC dose 2 or Placebo
Drug: Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 2
Experimental: Cohort 3
MPC dose 3 or Placebo
Drug: Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 3

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male and female subjects who are ≥ 18 and ≤ 80 years old
  • Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin > 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose > 1000 mg/day documented in the subject's history
  • HbA1c > 7.0% and < 10.5% at Screening
  • C-peptide > 0.8 ng/mL at Screening
  • Body mass index (BMI) > 22 and < 45 kg/m2 at Screening
  • Body weight < 150 kg at Screening

Key Exclusion Criteria:

  • Prior participation in any stem cell study
  • Women who are pregnant, intending to become pregnant during the study period or currently lactating
  • History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverage. Current cigarette smoking > 10 cigarettes per day
  • Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (> 2 episodes/week) within one month prior to Screening
  • Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for < 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
  • Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576328

Locations
United States, California
SC Clinical Research
Garden Grove, California, United States, 92844
United States, Florida
Diabetes Research Institute
Miami, Florida, United States, 33136
Compass Research
Orlanda, Florida, United States, 32806
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Wasatch Clinical Research
Salt Lake City, Louisiana, United States
United States, Montana
Big Sky Clinical Research
Butte, Montana, United States, 59701
United States, Nevada
Desert Endocrinology Clinical Research Center-Henderson
Henderson, Nevada, United States, 89052
Alliance Against Diabetes/AAD Clinical Research
Las Vegas, Nevada, United States, 89101
United States, New Hampshire
Active Practices and Research
Newington, New Hampshire, United States, 03801
United States, Ohio
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Providence Health Partners - Center for Clinical Reseach
Dayton, Ohio, United States, 45439
United States, Texas
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
West Houston Clinical Research Services
Houston, Texas, United States
Paragon Research Center
San Antonio, Texas, United States, 78205
United States, Virginia
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, United States, 23502
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States, 23294
United States, Washington
Capital Clinical Research Center
Olympia, Washington, United States, 98502
Sponsors and Collaborators
Mesoblast, Ltd.
  More Information

No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01576328     History of Changes
Other Study ID Numbers: MSB-DM003
Study First Received: April 9, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014