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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Insulin-Dependent, Juvenile Diabetes

In brief

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

Key facts

Study ID

NCT00690066

Run by

Mesoblast, Inc.

People needed

63

Starts

2008-06-11

Expected to finish

2011-12-19

Last updated by the study team

2026-03-11

Who can join

Age: 12 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria.
• Participant must be screened between 2 and 20 weeks from initial T1DM diagnosis
• Participants must be between the ages of 12 and 35 (inclusive).
• Participant must have at least one diabetes-related autoantibody present (either GAD or IA-2).
• Participant must have some beta cell function as determined by C-peptide testing (at least 0.2 pmol/mL (0.6 ng/mL) during MMTT.
• Participants 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%).
• Participants must be willing to comply with the schedule of study visits and protocol requirements.

You may not qualify if…

• Participant has Body Mass Index (BMI) ≥ 30.
• Participant has evidence of retinopathy at baseline.
• Participant has abnormally high lipid levels.
• Participant has abnormal blood pressure.
• Participant has an abnormal serum creatinine.
• Participant has evidence of clinically significant proteinuria.
• Participant has diabetic ketoacidosis.
• Participant is being treated for a severe active infection of any type.
• A female participant who is breast-feeding, pregnant, or intends to become pregnant during the study.
• Participant with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory).
• Participant has received an investigational drug (not approved by the FDA) for any indication 30 days prior to the screening visit.
• Participant is allergic to bovine or porcine products.
• Participant has evidence of active malignancy or prior history of active malignancy that has not been in remission for at least 5 years.
• Participant has any medical condition, which in the opinion of the Investigator, rendered his/her participation in this study unsuitable.

Where it is running

• University of Alabama, Division of Endocrinology & Metabolism — Birmingham, Alabama, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• Stanford University — Stanford, California, United States
• University of Florida — Gainesville, Florida, United States
• Diabetes Research Institute — Miami, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Desert Endocrinology CRC — Henderson, Nevada, United States
• Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
• University of North Carolina Diabetes Care Center — Chapel Hill, North Carolina, United States
• American Health Research, Inc. — Charlotte, North Carolina, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• Providence Health Partners - Center for Clinical Research — Dayton, Ohio, United States
• Cumberland Valley Endocrinology — Carlisle, Pennsylvania, United States
• AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Optimum Clinical Research, Inc. — Salt Lake City, Utah, United States
• The Strelitz Diabetes Center, Eastern VA Medical School — Norfolk, Virginia, United States
• University of Wisconsin Health- West Clinic — Madison, Wisconsin, United States
• Clinical and Transitional Science Institute — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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