Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

• Sponsor: Mesoblast, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01576328
• Collaborator: (none)
• Enrollment: 61
• Locations: 18
• Arms: 3
• Duration (Months): 42
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Mesenchymal Precursor Cells (MPCs); Drug: Mesenchymal Precursor Cells (MPCs); Drug: Mesenchymal Precursor Cells (MPCs)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Primary objective of the study is to assess the safety and tolerability of MPC therapy [116 Weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	SC Clinical Research	Garden Grove	California	United States	92844
2	Diabetes Research Institute	Miami	Florida	United States	33136
3	Compass Research	Orlando	Florida	United States	32806
4	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
5	Tulane University Medical Center	New Orleans	Louisiana	United States	70112
6	Big Sky Clinical Research	Butte	Montana	United States	59701
7	Desert Endocrinology Clinical Research Center-Henderson	Henderson	Nevada	United States	89052
8	Alliance Against Diabetes/AAD Clinical Research	Las Vegas	Nevada	United States	89101
9	Active Practices and Research	Newington	New Hampshire	United States	03801
10	The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio	United States	45219
11	Providence Health Partners - Center for Clinical Reseach	Dayton	Ohio	United States	45439
12	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States	75230
13	West Houston Clinical Research Services	Houston	Texas	United States	77055
14	Paragon Research Center	San Antonio	Texas	United States	78205
15	Wasatch Clinical Research	Salt Lake City	Utah	United States	84107
16	National Clinical Research - Norfolk, Inc	Norfolk	Virginia	United States	23502
17	National Clinical Research - Richmond, Inc.	Richmond	Virginia	United States	23294
18	Capital Clinical Research Center	Olympia	Washington	United States	98502

Sponsors and Collaborators

• Mesoblast, Ltd.

Investigators

• Study Director: K Segal, PhD, Mesoblast, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mesoblast, Ltd.
• ClinicalTrials.gov Identifier: NCT01576328
• Other Study ID Numbers: MSB-DM003
• First Posted: Apr 12, 2012
• Last Update Posted: Jun 2, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 2, 2020