Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Mesenchymal Precursor Cells (MPCs)
* Drug: Mesenchymal Precursor Cells (MPCs)
* Drug: Mesenchymal Precursor Cells (MPCs)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>MPC dose 1 or Placebo | Drug: Mesenchymal Precursor Cells (MPCs)<br>* Single intravenous infusion of MPCs Dose 1<br>|
| Experimental: Cohort 2<br>MPC dose 2 or Placebo | Drug: Mesenchymal Precursor Cells (MPCs)<br>* Single intravenous infusion of MPCs Dose 2<br>|
| Experimental: Cohort 3<br>MPC dose 3 or Placebo | Drug: Mesenchymal Precursor Cells (MPCs)<br>* Single intravenous infusion of MPCs Dose 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |