Clinical Research
Clinical Trials in Abdominal Transplantation
Clinical trials within the Divison of Abdominal Transplantation include: Tolerance Induction, EVB-induced post-transplant lymphoma, and the following Stanford-based trials for liver, kidney, intestine, pacreas, diabetes, and hepatocellular carcinoma.
This page provides an auto-populated up-to-date list of Stanford Clinical Trials in: liver, kidney, intestine, pancreas, diabetes, hepatocellular carcinoma, and pediatric transplant.
ATG-GCSF in New Onset Type 1 Diabetes
This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D).
The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.
Stanford is currently accepting patients for this trial.
Intervention(s):
- drug: Granulocyte colony stimulating factor (GCSF)
- drug: Placebo (for GCSF)
- drug: Anti-Thymocyte Globulin (ATG)
- drug: Placebo (for ATG)
Eligibility
Inclusion Criteria:
- Must be > 12 years < 46
- Must have a diagnosis of T1D for less than 100 days at randomization
- Willing to provide Informed Consent or have a parent or legal guardian provide
informed consent if the subject is <18 years of age
- Positive for at least one islet cell autoantibody; glutamic acid decarboxylase 65
(GAD65A), Insulin micro IAA (mIAA), if obtained within 10 days of the onset of insulin
therapy, islet antigen 2 (IA-2A), Islet Cell Antigen (ICA), or zinc transporter 8
(ZnT8A)
- Must have stimulated C-peptide levels = 0.2 pmol/ml measured during a mixed meal
tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within
one month (37 days) of randomization
- Must be Epstein-Barr virus (EBV PCR) negative within two weeks of randomization if EBV
seronegative at screening
- Be at least 6 weeks from last live immunization
- Participants are required to receive killed influenza vaccination at least 2 weeks
prior to randomization when vaccine for the current or upcoming flu season is
available
- Be willing to forgo vaccines during the treatment period and for 3 months following
last dose of study drug
- Be willing to comply with intensive diabetes management
Exclusion Criteria:
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (<
3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800
lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL).
- Have active signs or symptoms of acute infection at the time of randomization
- Have evidence of prior or current tuberculosis infection as assessed by purified
protein derivative (PPD), interferon gamma release assay (IGRA) or by history
- Be currently pregnant or lactating, or anticipate getting pregnant within the two year
study period
- Require use of other immunosuppressive agents including chronic use of systemic
steroids
- Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or
Hepatitis C infection
- Have any complicating medical issues or abnormal clinical laboratory results that may
interfere with study conduct, or cause increased risk to include pre-existing cardiac
disease, chronic obstructive pulmonary disease (COPD), sickle cell disease,
neurological, or blood count abnormalities
- Have a history of malignancies other than skin
- Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine
transaminase (ALT) greater than 3 times the upper limits of normal
- Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit
of normal
- Vaccination with a live virus within the last 6 weeks
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control
within prior 7 days of screening
- Active participation in another T1D treatment study in the previous 30 days
- Prior treatment with abatacept or anti-cd3
- Known allergy to GCSF or ATG
- Prior treatment with ATG or known allergy to rabbit derived products
- Any condition that in the investigator's opinion may adversely affect study
participation or may compromise the study results
Ages Eligible for Study
12 Years - 45 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting