| Ad Title: |
A Clinical Trial for Newly Diagnosed Type 1 Diabetes |
| Study 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) |
| Protocol Number: |
082008-024 |
| Department(s) involved in the Study: |
Int Med - Endocrinology
|
| Purpose of the Study: |
To Evaluate the effects and safety of an Intravenous Infusion of Adult Human Mesenchymal Stem Cells for treatment of Newly Diagnosed Type 1 diabetes |
| Participant Eligibility: |
Candidates must be 18- 30 years of age
Must be diagnosed with type 1 diabetes mellitus based on accepted criteria
On laboratory testing, must have presence of at least one diabetes related auto-antibody (IA-2 and GAD)commonly seen in people with type 1 diabetes.
On Laboratory Testing must have evidence of beta cell function still present. (measurement of stimulated c-peptide level of 0.2 pmol/mL)
Must be willing to comply with intensive diabetes management as directed.
|
| Disease/Condition Under Study: |
Type 1 diabetes Mellitus, previously known as juvenile diabetes,or insulin-dependent diabetes |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Prochymal (ex vivo cultured adult human mesenchymal stem cells
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Philip Raskin |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Aston Ambulatory Care Center
|
Yes
|
|
UT Southwestern Medical Center, Other: See Comments
|
Yes
|
|
| Contact Phone: |
214_648_4717 |
| Email: |
maria.pruneda@utsouthwestern.edu |
| Other Information: |
Laboratory testing and ECG are done at no cost to the participant
Physician evaluation throughout the study at no cost to participant
Diabetes education provided at all visits with educational materials at no cost |
| Website Keywords: |
Diabetes, Endocrinology
|
| Medical Keywords: |
Newly Diagnosed Type 1 Diabetes
|
