Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576328
• Other study ID #: MSB-DM003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2020
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 1
• Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 2
• Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 3

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Big Sky Clinical Research	Butte	Montana
United States	The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Providence Health Partners - Center for Clinical Reseach	Dayton	Ohio
United States	SC Clinical Research	Garden Grove	California
United States	Desert Endocrinology Clinical Research Center-Henderson	Henderson	Nevada
United States	West Houston Clinical Research Services	Houston	Texas
United States	Alliance Against Diabetes/AAD Clinical Research	Las Vegas	Nevada
United States	Diabetes Research Institute	Miami	Florida
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Active Practices and Research	Newington	New Hampshire
United States	National Clinical Research - Norfolk, Inc	Norfolk	Virginia
United States	Capital Clinical Research Center	Olympia	Washington
United States	Compass Research	Orlando	Florida
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Paragon Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective of the study is to assess the safety and tolerability of MPC therapy	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	116 Weeks