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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Osiris Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00690066
First received: June 2, 2008
Last updated: February 7, 2011
Last verified: February 2011

June 2, 2008
February 7, 2011
June 2008
December 2010   (final data collection date for primary outcome measure)
C-peptide AUC response (MMTT) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690066 on ClinicalTrials.gov Archive Site
  • Peak C-peptide response (MMTT) [ Designated as safety issue: No ]
  • Basal C-peptide response [ Designated as safety issue: No ]
  • Total daily insulin dose (units/kg) [ Designated as safety issue: No ]
  • Glycosylated hemoglobin (HbA1c) levels [ Designated as safety issue: No ]
  • Number of severe and documented hypoglycemic events [ Designated as safety issue: No ]
  • Changes in levels of GAD or IA-2 autoantibodies [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 (T1DM)

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.

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), which is being studied in this trial, is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. These cells are called beta cells. As beta cells are destroyed, less insulin can be made. This causes blood sugar levels to increase above normal and can cause life-threatening hypo- and hyper-glycemic reactions. For this reason, people with type 1 diabetes must take insulin to help control their blood sugar levels. Over time, poorly controlled diabetes can lead to a variety of serious health conditions, including heart disease, stroke, blindness, amputations, kidney disease, and nerve damage. Insulin is the primary method of controlling diabetes by regulating blood glucose levels, but it may not reverse or prevent disease progression. The active ingredient in ROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been shown to interact with the immune cells in the body, reducing inflammation and assisting in tissue repair. This study will help determine whether MSCs can protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in insulin production and decrease in circulating blood glucose. The characteristics and biologic activity of PROCHYMAL®, along with a good safety profile in human trials to date, suggest that PROCHYMAL® may be a good candidate for addressing Type 1 Diabetes.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 1 Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Insulin-Dependent
  • Drug: PROCHYMAL®
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
    Other Names:
    • ex vivo cultured adult human mesenchymal stem cells
    • Prochymal
  • Drug: Placebo
    Intravenous infusion of excipients of PROCHYMAL®
  • Experimental: A
    PROCHYMAL®
    Intervention: Drug: PROCHYMAL®
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have a diagnosis of type 1 diabetes mellitus based on the 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
  • 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
  • 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)
  • 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
Both
12 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690066
901
Yes
Nancy Massoni, Osiris Therapeutics, Inc.
Osiris Therapeutics
Juvenile Diabetes Research Foundation
Not Provided
Osiris Therapeutics
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP