NCT00305344

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 10, 2012

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

6.1 years

First QC Date

March 17, 2006

Results QC Date

March 2, 2012

Last Update Submit

February 3, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusUmbilical CordRegenerationInsulinIslets of Langerhans

Outcome Measures

Primary Outcomes (1)

  • Children With T1D Underwent a Single Autologous UCB Transfusion

    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

    Baseline to Year 2

Study Arms (1)

Cord Blood

ACTIVE COMPARATOR

Umbilical Cord Blood

Procedure: Autologous Umbilical Cord Blood TransfusionBiological: Cord blood

Interventions

Autologous Umbilical Cord Blood TransfusionPROCEDURE

Cord Blood infusion

Also known as: Cord Blood
Cord Blood
Cord bloodBIOLOGICAL

Develop Cord blood vaccine

Also known as: Vaccine
Cord Blood

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

  • Haller MJ, Wasserfall CH, Hulme MA, Cintron M, Brusko TM, McGrail KM, Sumrall TM, Wingard JR, Theriaque DW, Shuster JJ, Atkinson MA, Schatz DA. Autologous umbilical cord blood transfusion in young children with type 1 diabetes fails to preserve C-peptide. Diabetes Care. 2011 Dec;34(12):2567-9. doi: 10.2337/dc11-1406. Epub 2011 Oct 19.

    PMID: 22011412RESULT

  • 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. doi: 10.2337/dc09-0967.

    PMID: 19875605RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Limitations and Caveats

Small sample size. No randomized control group

Results Point of Contact

Title
Dr Michael Haller
Organization
University of Florida
hallemj@peds.ufl.edu
352.273.9264

Study Officials

  • Michael J Haller, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Desmond A Schatz, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 21, 2006

Study Start

April 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 9, 2022

Results First Posted

July 10, 2012

Record last verified: 2022-02

Locations

US(1)