NCT00873925

Brief Summary

In this pilot study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty acid supplementation can preserve beta cell function (prolong "honeymoon") in children with type 1 diabetes. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control. 15 Subjects will be randomized such that 2 of every 3 (10 total) will receive cord blood plus vitamin D and Omega 3 while 1 of 3 (5 total) will serve as controls and will not receive cord blood, vitamin D, or Omega 3 supplementation. The study will involve 5 visits over 1 year to the University of Florida This study is a follow-up to our initial study of cord blood infusion alone in which 23 children received autologous cord blood. The initial study was 100% safe but additional studies like the one described above are needed to determine how to improve cord blood based therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2009

Typical duration 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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

April 1, 2009

Last Update Submit

April 1, 2013

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • C-Peptide following the 1 year mixed meal tolerance test

    1 year post cord blood infusion

Secondary Outcomes (4)

  • DHA Level

    1 year post randomization

  • Vitamin D Level

    1 year post randomization

  • HbA1c and Insulin Dose

    1 year post randomization

  • Peripheral Blood T-cell assays

    1 year post randomization

Study Arms (2)

Autologous UCB Plus Vit D Omega 3 FA

EXPERIMENTAL

A single autologous (self) intravenous umbilical cord blood infusion followed by 1 year of daily Vitamin D and Omega 3 Fatty Acid supplementation give as liquid drops and gel capsules that can be swallowed or added to food

Biological: Autologous UCBDietary Supplement: Omega 3 FADietary Supplement: Vitamin D

Control

NO INTERVENTION

Subjects randomized to be controls will continue to use intensive insulin therapy in order to compare c-peptide production at 1 year in those receiving combination therapy vs those who do not

Interventions

Autologous UCBBIOLOGICAL

Umbilical Cord Blood stem cells CAN be collected and frozen immediately after birth in private and public cord blood banks. If a child with recent onset T1D has their OWN cord blood in storage they may qualify for this study. The cells would be released to the University of Florida where we would perform a single IV infusion of the cells once they have been thawed and washed. Depending on how the cells are stored, it may be possible to keep some portion of the cells in storage for future use.

Autologous UCB Plus Vit D Omega 3 FA
Omega 3 FADIETARY_SUPPLEMENT

Omega 3 Fatty Acids commonly found in fish oil may play an important role in preserving beta cell function via their anti-inflammatory actions. Those subjects randomized to treatment will take a daily supplement supplied as a capsule that can either be swallowed whole or opened so the contents can be mixed with food.

Autologous UCB Plus Vit D Omega 3 FA
Vitamin DDIETARY_SUPPLEMENT

Vitamin D is important for calcium absorption and bone health but may also play an important role in promoting healthy immune responses. Subjects randomized to intervention will take vitamin D supplied as a liquid in a dropper (1 drop per day added to food) for 1 year.

Autologous UCB Plus Vit D Omega 3 FA

Eligibility Criteria

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

You may qualify if:

  • TID diagnosis confirmed by presence of at least 1 diabetes autoantibody Children ≥ 1 years
  • Stored autologous umbilical cord blood (15 sought) in an AABB and/or FACT accredited cord bank.
  • Stimulated C-peptide \> 0.2pmol/L on MMTT
  • Cord blood meets all selection and testing criteria (see below).
  • Normal screening values for CBC, Renal function and electrolytes (BMP with Ca, Mg, and Phos).
  • 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 mother's 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).
  • Allergy to DHA (Omega 3) or Vitamin D
  • Hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (2)

  • Haller MJ, Viener HL, Wasserfall C, Brusko T, Atkinson MA, Schatz DA. Autologous umbilical cord blood infusion for type 1 diabetes. Exp Hematol. 2008 Jun;36(6):710-5. doi: 10.1016/j.exphem.2008.01.009. Epub 2008 Mar 20.

    PMID: 18358588BACKGROUND

  • Haller MJ, Wasserfall CH, Hulme MA, Cintron M, Brusko TM, McGrail KM, Wingard JR, Theriaque DW, Shuster JJ, Ferguson RJ, Kozuch M, Clare-Salzler M, Atkinson MA, Schatz DA. Autologous umbilical cord blood infusion followed by oral docosahexaenoic acid and vitamin D supplementation for C-peptide preservation in children with Type 1 diabetes. Biol Blood Marrow Transplant. 2013 Jul;19(7):1126-9. doi: 10.1016/j.bbmt.2013.04.011. Epub 2013 Apr 20.

    PMID: 23611977DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael J Haller, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2012

Study Completion

October 1, 2012

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)