Phase 2 N=23 Treatment

Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

Type 1 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00305344 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Children With T1D Underwent a Single Autologous UCB Transfusion — -0.6 ng /ml /120 min — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Autologous Umbilical Cord Blood Transfusion (Procedure); Cord blood (Biological)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Children With T1D Underwent a Single Autologous UCB Transfusion	-0.6	>0.05

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 diagnosed Type 1 Diabetes (T1D) who alo has their OWN cord blood in storage.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00305344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.