Cord Blood Plus Vitamin D and Omega 3s in T1D
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Hypothesis: We hypothesize that the combination of intensive insulin therapy, autologous
      umbilical cord blood (UCB), Vitamin D, and Omega 3 fatty acids administered to children with
      T1D will preserve residual c-peptide when compared to children receiving intensive insulin
      therapy alone

      Specific Aims:

        1. Randomize 15 children with recent onset T1D and available autologous cord blood such
           that 10 receive a combination of intensive insulin therapy, autologous UCB infusion, and
           daily Vitamin D while 5 receive intensive insulin therapy alone

        2. Document safety of combination therapy

        3. Study potential changes in glucose metabolism

        4. Study potential changes in immune function

      Preliminary Studies: Our group has already performed autologous cord blood infusion in 23
      children with T1D and has documented the safety of this approach. While conclusive data
      regarding the efficacy of the infusion in preserving beta cell function are lacking, our
      pilot study has demonstrated a potential for cord blood to low the rate of c-peptide decline
      (a measure of beta cell function/mass) in these young children with T1D. As documented above,
      considerable work both here and other institutions suggests the potential for a combination
      of Vitamin D and DHA to further augment the autoimmune response. Given the safety and
      potential efficacy of such an approach, we feel that a pilot study of the combination of UCB
      infusion, vitamin D supplementation, and DHA supplementation is warranted.

      Screening: Only subjects who are still making at least a small amount of detectable insulin
      will be eligible for this study. To determine if a child is still making insulin, they will
      undergo a mixed meal tolerance test. This involves placing an IV in the morning prior to
      eating. The subject then drinks a "mixed meal" (the nutritional supplement Boost is used)and
      blood is taken via the IV at timepoints over the next 2 hours to determine if insulin is
      still being produced.

      Randomization: If a potential subject "passes" the screening test, they will then be
      randomized to either receiving the study intervention or to being a control. Subjects WILL be
      told what arm of the study they are randomized to.

      Infusion: Those randomized to infusion will return to the University of Florida for a single
      autologous cord blood infusion and will be given vitamin D and Omega 3 supplements

      Follow-up: Both Control and Intervention subjects will return at 3, 6, and 12 months after
      the infusion/screening visit to have blood drawn for a repeat mixed meal tolerance test,
      measurement of HbA1c, and other immune studies.
    

Intervention name(s): Autologous UCB; Omega 3 FA; Vitamin D
Intervention type(s): Biological; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes