Umbilical Cord Blood Infusion to Treat Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00305344 |
Recruitment Status :
Completed
First Posted : March 21, 2006
Results First Posted : July 10, 2012
Last Update Posted : February 9, 2022
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Sponsor:
University of Florida
Collaborators:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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Umbilical Cord Recipient |
Period Title: Overall Study | |
Started | 23 |
Completed | 23 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Cord Blood Recipient | |
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Umbilical Cord Recipient | |
Overall Number of Baseline Participants | 23 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | |
<=18 years |
23 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 23 participants | |
5.1 (1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | |
Female |
14 60.9%
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Male |
9 39.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 23 participants |
23 |
Outcome Measures
Adverse Events
Limitations and Caveats
Small sample size. No randomized control group
More Information
Results Point of Contact
Name/Title: | Dr Michael Haller |
Organization: | University of Florida |
Phone: | 352.273.9264 |
EMail: | hallemj@peds.ufl.edu |
Publications of Results:
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: | February 9, 2022 |