Umbilical Cord Blood Infusion to Treat Type 1 Diabetes

This study has been completed.

First Received on March 17, 2006. Last Updated on September 16, 2011 History of Changes

Sponsor:	University of Florida
Collaborators:	Juvenile Diabetes Research Foundation National Institutes of Health (NIH)
Information provided by (Responsible Party):	University of Florida
ClinicalTrials.gov Identifier:	NCT00305344

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 who alo has their OWN cord blood in storage.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Procedure: Autologous Umbilical Cord Blood Transfusion	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Blood Transfusion and Donation Diabetes Medicines Diabetes Type 1

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Peak C-peptide following Mixed Meal Tolerance Test [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
MMTT

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

Intervention Details:

Cord Blood infusion

Other Name: Cord Blood

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

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

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haller MJ, Wasserfall CH, McGrail KM, Cintron M, Brusko TM, Wingard JR, Kelly SS, Shuster JJ, Atkinson MA, Schatz DA. Autologous umbilical cord blood transfusion in very young children with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2041-6.

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
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration; University of Florida: IRB-01; 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 February 09, 2012