PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus
1 other identifier
interventional
63
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2008
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedStudy Start
First participant enrolled
June 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2011
CompletedMarch 11, 2026
November 1, 2025
2.5 years
June 2, 2008
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C-peptide area under the concentration curve (AUC) response (MMTT)
1 year
Secondary Outcomes (6)
Peak C-peptide response (MMTT)
2 years
Basal C-peptide response
2 years
Total daily insulin dose (units/kg)
2 years
Glycosylated hemoglobin (HbA1c) levels
2 years
Number of severe and documented hypoglycemic events
2 years
- +1 more secondary outcomes
Study Arms (2)
Prochymal
EXPERIMENTALPROCHYMAL®
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (20)
University of Alabama, Division of Endocrinology & Metabolism
Birmingham, Alabama, 35294, United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32610, United States
Diabetes Research Institute
Miami, Florida, 33136, United States
University of Kentucky
Lexington, Kentucky, 40502, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Desert Endocrinology CRC
Henderson, Nevada, 89052, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
University of North Carolina Diabetes Care Center
Chapel Hill, North Carolina, 27599, United States
American Health Research, Inc.
Charlotte, North Carolina, 28207, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439, United States
Cumberland Valley Endocrinology
Carlisle, Pennsylvania, 17015, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102, United States
The Strelitz Diabetes Center, Eastern VA Medical School
Norfolk, Virginia, 23510, United States
University of Wisconsin Health- West Clinic
Madison, Wisconsin, 53717, United States
Clinical and Transitional Science Institute
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahboob Rahman, MD
Mesoblast, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
June 11, 2008
Primary Completion
December 12, 2010
Study Completion
December 19, 2011
Last Updated
March 11, 2026
Record last verified: 2025-11