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View Clinical Trial (Medical Research Study)
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PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) - NCT00690066-92037 (Clinical Trial 224519)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy224519.aspx
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| City: |
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LaJolla |
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State:
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CA |
| Zip Code: |
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92037 |
| Conditions: |
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Type 1 Diabetes Mellitus - Type 1 Diabetes - Diabetes Mellitus, Insulin-Dependent - Juvenile Diabetes |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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January 19, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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