Status:
COMPLETED
Cord Blood Plus Vitamin D and Omega 3s in T1D
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
In this pilot study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty acid supplementat...
Detailed Description
Hypothesis: We hypothesize that the combination of intensive insulin therapy, autologous umbilical cord blood (UCB), Vitamin D, and Omega 3 fatty acids administered to children with T1D will preserve ...
Eligibility Criteria
Inclusion
- TID diagnosis confirmed by presence of at least 1 diabetes autoantibody Children ≥ 1 years
- Stored autologous umbilical cord blood (15 sought) in an AABB and/or FACT accredited cord bank.
- Stimulated C-peptide \> 0.2pmol/L on MMTT
- Cord blood meets all selection and testing criteria (see below).
- Normal screening values for CBC, Renal function and electrolytes (BMP with Ca, Mg, and Phos).
- 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 mother's 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).
- Allergy to DHA (Omega 3) or Vitamin D
- Hypercalcemia
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00873925
Start Date
March 1 2009
End Date
October 1 2012
Last Update
April 4 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Florida
Gainesville, Florida, United States, 32608