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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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Procedure: Autologous Umbilical Cord Blood Transfusion Biological: Cord blood||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: Cord Blood
Umbilical Cord Blood
Procedure: Autologous Umbilical Cord Blood Transfusion
Cord Blood infusion
Other Name: Cord Blood
Biological: Cord blood
Develop Cord blood vaccine
Other Name: Vaccine
- Children With T1D Underwent a Single Autologous UCB Transfusion [ Time Frame: Baseline to Year 2 ]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 insulin 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
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|Ages Eligible for Study:||1 Year and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305344
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael J Haller, MD||University of Florida|
|Principal Investigator:||Desmond A Schatz, MD||University of Florida|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
GCRC 593 ( Other Identifier: General Clinical Research Center )
UF IRB-01 125-2004 ( Other Identifier: UF Institutional Review Board )
|First Posted:||March 21, 2006 Key Record Dates|
|Results First Posted:||July 10, 2012|
|Last Update Posted:||February 9, 2022|
|Last Verified:||February 2022|
Type 1 Diabetes Mellitus
Islets of Langerhans
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Physiological Effects of Drugs