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: July 9, 2013
Last verified: July 2013

April 9, 2012
July 9, 2013
April 2012
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01576328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Mesenchymal Precursor Cells (MPCs)
    Single intravenous infusion of MPCs Dose 1
  • Drug: Mesenchymal Precursor Cells (MPCs)
    Single intravenous infusion of MPCs Dose 2
  • Drug: Mesenchymal Precursor Cells (MPCs)
    Single intravenous infusion of MPCs Dose 3
  • Experimental: Cohort 1
    MPC dose 1 or Placebo
    Intervention: Drug: Mesenchymal Precursor Cells (MPCs)
  • Experimental: Cohort 2
    MPC dose 2 or Placebo
    Intervention: Drug: Mesenchymal Precursor Cells (MPCs)
  • Experimental: Cohort 3
    MPC dose 3 or Placebo
    Intervention: Drug: Mesenchymal Precursor Cells (MPCs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2015
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01576328
MSB-DM003
Yes
Mesoblast, Ltd.
Mesoblast, Ltd.
Not Provided
Not Provided
Mesoblast, Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP