Cord Blood Combination Study
Note: This study is no longer recruiting new participants.
Study Name: Cord Blood Combination with Vitamin D and Omega-3
Principal Investigator: Michael J. Haller, M.D.
Study Coordinator: Miriam Cintron
Phone: (352) 273-9264 or (352) 273-9263
Email: Michael Haller or Miriam Cintron (firstname.lastname@example.org)
What is the Cord Blood Combination Study?
In this phase 2 study we 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. We will enroll 15 children with recent onset type 1 diabetes and available cord blood. Ten will receive a combination of intensive insulin therapy, cord blood infusion, daily supplements while the other 5 will receive intensive insulin therapy alone.
Who can participate?
Children age 1 and up with a recent diagnosis of type 1 diabetes who have their own stored cord blood.
What do I have to do as a participant?
For this study you will be randomly assigned (much like the flip of a coin) to either the Treatment group or Control group. You will be expected to come to the General Clinical Research Center (GCRC) at Shands Hospital. In the GCRC we will do screening tests and the follow-up visits. Only subjects who are still making at least a small amount of detectable insulin will be eligible for this study. 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. 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 Both Control and Treatment groups 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.