Type 1 Diabetes Clinical Trial
Official title:
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
NCT number | NCT00690066 |
Other study ID # | 901 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 11, 2008 |
Est. completion date | December 19, 2011 |
Verified date | December 2021 |
Source | Mesoblast, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | December 19, 2011 |
Est. primary completion date | December 12, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 35 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | AM Diabetes & Endocrinology Center | Bartlett | Tennessee |
United States | University of Alabama, Division of Endocrinology & Metabolism | Birmingham | Alabama |
United States | Cumberland Valley Endocrinology | Carlisle | Pennsylvania |
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 | The University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Providence Health Partners - Center for Clinical Research | Dayton | Ohio |
United States | University of Florida | Gainesville | Florida |
United States | Desert Endocrinology CRC | Henderson | Nevada |
United States | Scripps Whittier Diabetes Institute | La Jolla | California |
United States | Nevada Alliance Against Diabetes | Las Vegas | Nevada |
United States | University of Kentucky | Lexington | Kentucky |
United States | University of Wisconsin Health- West Clinic | Madison | Wisconsin |
United States | Diabetes Research Institute | Miami | Florida |
United States | Clinical and Transitional Science Institute | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | The Strelitz Diabetes Center, Eastern VA Medical School | Norfolk | Virginia |
United States | Optimum Clinical Research, Inc. | Salt Lake City | Utah |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Mesoblast, Inc. | Juvenile Diabetes Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-peptide area under the concentration curve (AUC) response (MMTT) | 1 year | ||
Secondary | Peak C-peptide response (MMTT) | 2 years | ||
Secondary | Basal C-peptide response | 2 years | ||
Secondary | Total daily insulin dose (units/kg) | 2 years | ||
Secondary | Glycosylated hemoglobin (HbA1c) levels | 2 years | ||
Secondary | Number of severe and documented hypoglycemic events | 2 years | ||
Secondary | Changes in levels of glutamic acid decarboxylase (GAD) or islet antigen 2 (IA-2) autoantibodies | 2 years |
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