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Trial record 2 of 2 for:    cord blood diabetes university of florida

Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00305344
First received: March 17, 2006
Last updated: July 3, 2012
Last verified: July 2012
Results First Received: March 2, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Procedure: Autologous Umbilical Cord Blood Transfusion
Biological: Cord blood

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
23 total subjects were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with autologous cord blood in private storage facilities were eligible. No eligible patients were excluded.

Reporting Groups
  Description
Cord Blood Recipient Umbilical Cord Recipient

Participant Flow:   Overall Study
    Cord Blood Recipient  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cord Blood Recipient Umbilical Cord Recipient

Baseline Measures
    Cord Blood Recipient  
Number of Participants  
[units: participants]
  23  
Age  
[units: participants]
 
<=18 years     23  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.1  ± 1  
Gender  
[units: participants]
 
Female     14  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     23  



  Outcome Measures

1.  Primary:   Children With T1D Underwent a Single Autologous UCB Transfusion   [ Time Frame: Baseline to Year 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size. No randomized control group


  More Information
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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:  
Name/Title: Dr Michael Haller
Organization: University of Florida
phone: 352.273.9264
e-mail: hallemj@peds.ufl.edu


Publications of Results:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00305344     History of Changes
Other Study ID Numbers: 1-2005-362, GCRC 593, UF IRB-01 125-2004
Study First Received: March 17, 2006
Results First Received: March 2, 2012
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
University of Florida: Pediatric Data Safety Monitoring Board