Status:
UNKNOWN
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
Lead Sponsor:
Technical University of Munich
Conditions:
Type 1 Diabetes
Children
Eligibility:
All Genders
1+ years
Phase:
PHASE1
Brief Summary
Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality. Patients require multiple daily insulin injections throughout their lives as well as close monitoring of t...
Eligibility Criteria
Inclusion
- Must have a diagnosis of T1D and have stored umbilical cord blood (10 patients sought) at the cord bank Vita 34.
- 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).
- Normal screening values for CBC, Renal function and electrolytes (BMP).
- Willing to comply with intensive diabetes management
- Not younger than 1 year of age
Exclusion
- Have complicating medical issues that would interfere with blood drawing or monitoring.
- Require chronic use of steroids or other immunosuppressive agents for other conditions.
- Cord Blood with viability \< 50%.
- 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 :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00989547
Start Date
September 1 2008
Last Update
July 23 2013
Active Locations (1)
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1
Forschergruppe Diabetes der Technischen Universität
München, Bavaria, Germany, 80804