Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01285934
Eligibility Criteria:
Inclusion Criteria:
* Ages 16 to 35 years old
* A diagnosis of type 1 diabetes by hyperglycemia and at least 1 antibody to islet cell autoantigen: GAD, IAA, ICA, IA-2, or Slc30A8
* Fasting C-peptide \> 0.20 nmol / liter
* Enrollment within 5 months of T1D diagnosis
* Eligible patients must be referred to a fertility / reproductive endocrinologist and have written documentation of medical counseling advising patients about the risk of infertility and the possible options of sperm and oocyte banking before enrollment.
Exclusion Criteria:
* HIV positive
* Patients in the honeymoon phase not taking insulin
* Hepatitis A, B, or C positive
* On corticosteroids or other immune suppressive medications
* History of diabetic ketoacidosis
* Ongoing malignancy except localized treated basal cell or squamous skin cancer.
* History of cardiac disease or congestive heart failure or ventricular tachycardia or abnormal dobutamine cardiac echocardiogram
* Positive pregnancy test, inability or unwillingness to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a potential side effect of therapy.
* Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
* DLCO \< 60% of predicted
* Resting LVEF \< 45%
* Creatinine \> 1.5 mg/dl
* Known hypersensitivity to E Coli derived proteins.
* Transaminases greater than 2 times normal
* Positive tuberculosis skin test
* Any active infection
* Any co-morbid illness that in the opinion of the investigator would jeopardize the ability of the subject to tolerate the study.
* Failure to collect at least 2.0 x 106 CD34+ cells/kg
* History of alcohol or illicit drug abuse
* Unwilling to be compliant with change in life-style-diet and exercise
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT01285934
Study Brief:
Protocol Section:
NCT01285934