Status:
COMPLETED
Umbilical Cord Blood Infusion to Treat Type 1 Diabetes
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
1+ years
Phase:
PHASE1
PHASE2
Brief Summary
While this study is now completely enrolled, we do hope to develop a "next generation" cord blood based study sometime in early 2009. Please continue to contact us if you have a child with newly diagn...
Detailed Description
Objective: Our goal is to transfuse autologous umbilical cord blood into 23 children with T1D in an attempt to re-establish immune tolerance and perhaps regenerate pancreatic islet insulin-producing ...
Eligibility Criteria
Inclusion
- Must have a diagnosis of T1D and have stored umbilical cord blood in an AABB and/or FACT accredited cord bank.
- TID diagnosis will be defined as having a clear history of polydipsia, polyphagia, polyuria, and weight loss consistent with a clinical diagnosis, diagnosis will mot be based solely upon the presence of autoantibodies.
- Cord blood meets all selection and testing criteria (see below).
- Able to complete mixed meal tolerance / glucagon stimulation test.
- Normal screening values for CBC, Renal function and electrolytes (BMP).
- Willing to comply with intensive diabetes management
Exclusion
- Complicating medical issues that would interfere with blood drawing or monitoring.
- Chronic use of steroids or other immunosuppressive agents for other conditions.
- Positive infectious disease markers from mothers' blood or cord at time of collection (See below for details).
- Any evidence of illness on planned infusion date (i.e. fever \>38.5 C, vomiting, diarrhea, wheezing, or crackles).
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00305344
Start Date
April 1 2005
End Date
May 1 2011
Last Update
February 9 2022
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610