The second stage of an innovative trial using cord blood to treat children with Type 1 diabetes is now underway at the University of Florida College of Medicine. In this phase 2 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 the 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. The trial is due to completed in March.
Click here to listen to the interview with Doctor Desmond Schatz from the University of Florida about the trial and to read more about the details of the clinical trial, click here http://clinicaltrials.gov/ct2/show/NCT00873925