PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)

• Status: Completed
• Trial end date: 2011-12-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in subjects recently diagnosed with type 1 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast International Sàrl; Mesoblast, Inc.
• Collaborator: Juvenile Diabetes Research Foundation
• Treatments: Remestemcel-l

Criteria

Inclusion Criteria:

• Subject must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria

• Subject must be screened between 2 and 20 weeks from initial T1DM diagnosis

• Subject must be between the ages of 12 and 35 (inclusive)

• Subject must have at least one diabetes-related autoantibody present (either GAD or IA-2)

• Subject must have some beta cell function as determined by C-peptide testing (at least 0.2 pmol/mL (0.6 ng/mL) during MMTT

• Subject must be willing to comply with "intensive diabetes management" as directed by the Investigator with the goal of maintaining blood glucose as close to normal as possible (i.e., glycosylated hemoglobin A1c (HbA1c) value of ≤ 7.0%)

• Subject must be willing to comply with the schedule of study visits and protocol requirements

Exclusion Criteria:

• Subject has Body Mass Index (BMI) ≥ 30

• Subject has evidence of retinopathy at baseline

• Subject has abnormally high lipid levels

• Subject has abnormal blood pressure

• Subject has abnormal serum creatinine

• Subject has evidence of clinically significant proteinuria

• Subject has diabetic ketoacidosis

• Subject is being treated for severe active infection of any type

• A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study

• Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory)

• Subjects has received an investigational drug (not approved by the FDA) for any indication 30 days prior to screening visit

• Subject is allergic to bovine or porcine products

• Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years

• Subjects has any medical condition, which in the opinion of the Investigator, rendered his/her participation in this study unsuitable