PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) - Full Text View

Sponsors and Collaborators:	Osiris Therapeutics Juvenile Diabetes Research Foundation
Information provided by:	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00690066

Purpose

The objective of the present study is to establish the safety and efficacy of multiple administrations of PROCHYMAL™ in subjects recently diagnosed with type 1 diabetes mellitus.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus Type 1 Diabetes Diabetes Mellitus, Insulin-Dependent Juvenile Diabetes	Drug: PROCHYMAL™ Drug: Placebo	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 (T1DM)

Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:

C-peptide AUC response (MMTT) [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental PROCHYMAL™	Drug: PROCHYMAL™ Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
B: Placebo Comparator Placebo	Drug: Placebo Intravenous infusion of excipients of PROCHYMAL™

Detailed Description:

Diabetes mellitus refers to disorders in which the body has trouble regulating its blood glucose levels. There are two major types of diabetes: type 1 and type 2. Type 1 diabetes mellitus (T1DM), the indication being studied in this trial, is also called juvenile diabetes or insulin-dependent diabetes. T1DM is an autoimmune disorder where the immune system attacks and destroys the beta cells in the pancreas. Beta cells, contained within small islands of endocrine cells called the pancreatic islets, normally produce insulin. As beta cells are destroyed, less insulin can be produced, resulting in glucose accumulation in the blood. For this reason, people with type 1 diabetes must take insulin to regulate their blood sugar levels in order to avoid life-threatening hypo- and hyper-glycemic reactions. 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 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 this unmet medical need.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have a diagnosis of type 1 diabetes mellitus based on the ADA criteria
Subject must be screened between 2 and 16 weeks from initial T1DM diagnosis
Subject must be between the ages of 18 and 30 (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690066

Contacts

Contact: Dayna Buskirk

352-335-9383

osiris@osiris.com

Locations

United States, Alabama
University of Alabama, Division of Endocrinology & Metabolism	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Fernando Ovalle, M.D.
Principal Investigator: Fernando Ovalle, M.D.
United States, California
Stanford University	Not yet recruiting
Stanford, California, United States, 94305
Principal Investigator: Darrell Wilson, M.D.
United States, Florida
Diabetes Research Institute	Recruiting
Miami, Florida, United States, 33136
Contact: Jay Skyler, M.D.
Principal Investigator: Jay Skyler, M.D.
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Michale J Haller, M.D.
United States, Kentucky
University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40502
Principal Investigator: Dennis G Karounos, M.D.
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Antoinette Moran, M.D.
Principal Investigator: Antoinette Moran, M.D.
United States, Nevada
Nevada Alliance Against Diabetes	Recruiting
Las Vegas, Nevada, United States, 89101
Contact: Rubin Saavedra, M.D.
Principal Investigator: Rubin Saavedra, M.D.
United States, North Carolina
American Health Research, Inc.	Recruiting
Charlotte, North Carolina, United States, 28207
Principal Investigator: Selwyn Spangenthal, M.D.
University of North Carolina Diabetes Care Center	Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: John B Buse, M.D., Ph.D., FACE
United States, Ohio
Providence Health Partners - Center for Clinical Research	Recruiting
Dayton, Ohio, United States, 45439
Contact: Lawrence G Ratcliff, M.D.
Principal Investigator: Lawrence G Ratcliff, M.D.
The Lindner Clinical Trial Center	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dean Kereiakes, M.D.
Principal Investigator: Dean J Kereiakes, M.D.
United States, Tennessee
AM Diabetes & Endocrinology Center	Recruiting
Bartlett, Tennessee, United States
Contact: Kashif Latif, M.D.
Principal Investigator: Kashif Latif, M.D.
United States, Texas
The University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Philip Raskin, M.D.
Principal Investigator: Philip Raskin, M.D.
United States, Utah
Optimum Clinical Research, Inc.	Recruiting
Salt Lake City, Utah, United States, 84102
Principal Investigator: Jackson M Rhudy, M.D.
United States, Virginia
The Strelitz Diabetes Center, Eastern VA Medical School	Not yet recruiting
Norfolk, Virginia, United States, 23510
Principal Investigator: Aaron I Vinik, M.D., Ph.D.
United States, Wisconsin
University of Wisconsin Health- West Clinic	Not yet recruiting
Madison, Wisconsin, United States, 53717
Principal Investigator: Melissa Meredith, M.D.
Clinical and Transitional Science Institute	Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Shailesh Patel, M.D.

Sponsors and Collaborators

Osiris Therapeutics

Juvenile Diabetes Research Foundation

More Information

Responsible Party:	Osiris Therapeutics, Inc. ( Dayna Buskirk, Director, Clinical Development )
Study ID Numbers:	901
Study First Received:	June 2, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00690066
Health Authority:	United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:

Type 1 Diabetes Mellitus
Type 1 Diabetes
Diabetes Mellitus, Insulin-Dependent
Juvenile Diabetes
T1DM
Adult Human Stem Cells

Mesenchymal Stem Cells
MSCs
Insulin
Osiris
Prochymal

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009