This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

This study has been completed.
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida Identifier:
First received: March 17, 2006
Last updated: July 3, 2012
Last verified: July 2012
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: Intervention Model: Single Group Assignment
Masking: None (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:

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 ]
    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


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00305344

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)
Principal Investigator: Michael J Haller, MD University of Florida
Principal Investigator: Desmond A Schatz, MD University of Florida
  More Information

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 )
Study First Received: March 17, 2006
Results First Received: March 2, 2012
Last Updated: July 3, 2012

Keywords provided by University of Florida:
Type 1 Diabetes Mellitus
Umbilical Cord
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 processed this record on September 19, 2017