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Tracking Information | |||||
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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 † |
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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. |
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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. |
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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 † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 60 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 30 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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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. |