Status:
COMPLETED
PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Lead Sponsor:
Mesoblast, Inc.
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes Mellitus
Type 1 Diabetes
Eligibility:
All Genders
12-35 years
Phase:
PHASE2
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.
Detailed Description
Diabetes mellitus refers to disorders in which the body has trouble controlling its blood glucose levels. There are two main types of diabetes: type 1 and type 2. Type 1 diabetes mellitus (T1DM), whic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00690066
Start Date
June 11 2008
End Date
December 19 2011
Last Update
December 23 2021
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama, Division of Endocrinology & Metabolism
Birmingham, Alabama, United States, 35294
2
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
3
Stanford University
Stanford, California, United States, 94305
4
University of Florida
Gainesville, Florida, United States, 32610