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Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
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
History of Changes
  Purpose

While this study is now completely enrolled, we do hope to develop a "next generation" cord blood based study sometime in early 2009. Please continue to contact us if you have a child with newly diagnosed Type 1 Diabetes (T1D) who alo has their OWN cord blood in storage.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Procedure: Autologous Umbilical Cord Blood Transfusion
Biological: Cord blood
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Children With T1D Underwent a Single Autologous UCB Transfusion [ Time Frame: Baseline to Year 2 ] [ Designated as safety issue: No ]
    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


Enrollment: 23
Study Start Date: April 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have a diagnosis of T1D and have stored umbilical cord blood in an AABB and/or FACT accredited cord bank.
  2. 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.
  3. Cord blood meets all selection and testing criteria (see below).
  4. Able to complete mixed meal tolerance / glucagon stimulation test.
  5. Normal screening values for CBC, Renal function and electrolytes (BMP).
  6. Willing to comply with intensive diabetes management

Exclusion Criteria:

  1. Complicating medical issues that would interfere with blood drawing or monitoring.
  2. Chronic use of steroids or other immunosuppressive agents for other conditions.
  3. Positive infectious disease markers from mothers' blood or cord at time of collection (See below for details).
  4. Any evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305344

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Investigators
Principal Investigator: Michael J Haller, MD University of Florida
Principal Investigator: Desmond A Schatz, MD University of Florida
  More Information

Publications:

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

Keywords provided by University of Florida:
Type 1 Diabetes Mellitus
Umbilical Cord
Regeneration
Insulin
Islets of Langerhans

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013