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Trial record 1 of 30 for:    cord blood and type 1 diabetes
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Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00305344
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : July 10, 2012
Last Update Posted : July 10, 2012
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Procedure: Autologous Umbilical Cord Blood Transfusion
Biological: Cord blood
Enrollment 23
Recruitment Details 23 total subjects were enrolled.
Pre-assignment Details Patients with autologous cord blood in private storage facilities were eligible. No eligible patients were excluded.
Arm/Group Title Cord Blood Recipient
Hide Arm/Group Description Umbilical Cord Recipient
Period Title: Overall Study
Started 23
Completed 23
Not Completed 0
Arm/Group Title Cord Blood Recipient
Hide Arm/Group Description Umbilical Cord Recipient
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
23
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
5.1  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
14
  60.9%
Male
9
  39.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Children With T1D Underwent a Single Autologous UCB Transfusion
Hide Description All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insuln production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes
Time Frame Baseline to Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants received their own autologous umbilical cord blood (UCB)
Arm/Group Title Recipients Receiving Cord Blood
Hide Arm/Group Description:
Children with type 1 diabetes who underwent an autologous cord blood infusion
Overall Number of Participants Analyzed 23
Median (Inter-Quartile Range)
Unit of Measure: ng /ml /120 min
-0.6
(-1.0 to -0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Recipients Receiving Cord Blood
Comments Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cord Blood Recipients
Hide Arm/Group Description Children with type 1 diabetes who underwent an autologous cord blood infusion
All-Cause Mortality
Cord Blood Recipients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cord Blood Recipients
Affected / at Risk (%)
Total   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cord Blood Recipients
Affected / at Risk (%)
Total   0/23 (0.00%) 
Small sample size. No randomized control group
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Michael Haller
Organization: University of Florida
Phone: 352.273.9264
EMail: hallemj@peds.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00305344    
Other Study ID Numbers: 1-2005-362
GCRC 593 ( Other Identifier: General Clinical Research Center )
UF IRB-01 125-2004 ( Other Identifier: UF Institutional Review Board )
First Submitted: March 17, 2006
First Posted: March 21, 2006
Results First Submitted: March 2, 2012
Results First Posted: July 10, 2012
Last Update Posted: July 10, 2012