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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 2, 2008

Last Updated Date

May 8, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00690066 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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)

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Type 1 Diabetes Mellitus
Type 1 Diabetes
Diabetes Mellitus, Insulin-Dependent
Juvenile Diabetes

Intervention ^†

Drug: PROCHYMAL™
Drug: Placebo

Study Arms / Comparison Groups

Experimental: PROCHYMAL™
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Dayna Buskirk

352-335-9383

diabetes@osiris.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00690066

Responsible Party

Dayna Buskirk, Director, Clinical Development, Osiris Therapeutics, Inc.

Secondary IDs ^††

Study Sponsor ^†

Osiris Therapeutics

Collaborators ^††

Juvenile Diabetes Research Foundation

Investigators ^†

Information Provided By

Osiris Therapeutics

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.