Clinical trial NCT01576328: Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Primary objective of the study is to assess the safety and tolerability of MPC therapy
timeFrame: 116 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: SC Clinical Research
state: California
city: Miami
country: United States
facility: Diabetes Research Institute
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Butte
country: United States
facility: Big Sky Clinical Research
state: Montana
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center-Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Alliance Against Diabetes/AAD Clinical Research
state: Nevada
city: Newington
country: United States
facility: Active Practices and Research
state: New Hampshire
city: Cincinnati
country: United States
facility: The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center for Clinical Reseach
state: Ohio
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
Study officials:
affiliation: Mesoblast, Ltd.
name: K Segal, PhD
role: STUDY_DIRECTOR
References:
citation: Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.