ATG/GCSF Clinical Trial
Study Name: ATG/GCSF – No longer recruiting
Principal Investigators: Michael Haller, MD and Desmond Schatz, MD
Study Coordinator: Mary Alice Dennis, MSN, RN
Phone: (352) 273-9264, (352) 273-9361 or (352) 273-9265
What is the ATG/GCSF Study?
This is a new interventional study for people with established type 1 diabetes (T1D). The primary purpose of the study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (pegylated GCSF) to patients with established T1D is safe. The secondary purpose is to determine if giving ATG plus GCSF to patients with established TID will preserve insulin production.
Who can participate?
Participants must have well established T1D with a time from diagnosis of greater than 4 months but less than 2 years. The age range for participants is age 12 or greater and less than 45 years of age.
What do I have to do as a participant?
If you meet screening requirements (separate study visit) you will be admitted to the General Clinical Research Center (GCRC) at Shands Hospital at UF for 3-4 days for the ATG infusion. The GCSF will be given beginning at the end of the infusion, and then every 2 weeks for a total of 6 doses. There are 12 follow-up visits at 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months. Beginning with the 3 month visit, a mixed meal tolerance test (except for the 9 month visit) will be done at each visit along with blood tests at all visits. All follow-up visits take place at the GCRC.