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

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. Identifier: NCT00305344
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : July 10, 2012
Last Update Posted : July 10, 2012
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: 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

  Participant Flow

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
Cord Blood Recipient Umbilical Cord Recipient

Participant Flow:   Overall Study
    Cord Blood Recipient

  Baseline Characteristics

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
Cord Blood Recipient Umbilical Cord Recipient

Baseline Measures
   Cord Blood Recipient 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   23 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 5.1  (1) 
[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

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

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

Publications of Results:

Responsible Party: University of Florida Identifier: NCT00305344     History of Changes
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