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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00971503
Eligibility Criteria:
Inclusion Criteria:
* Between 18-30 years of age, diagnosed with diabetes mellitus Type 1 (insulin-dependent).
* Negative antibody titers for GAD and anti-islet.
* Measurements of serum C-peptide below normal values.
* BMI 20-25, men, 19-24, women
Exclusion Criteria:
* Diabetes type 2, gestational diabetes, and other types of secondary diabetes.
* Patients with acute metabolic complications of diabetes such as ketoacidosis at least within the last 6 months.
* Abdominal perimeter \>102 cm in men; \>88cm in women
* Fasting glycemia \>100 mg/dl, triglycerides \>150 mg/dl, HDL \< 40 mg/dl.
* Blood pressure: SBP \>135 mmHg and DBP \>85 mmHg at the time of randomization
* Patients with BMI \> 25 for men and \>24 for women.
* Patients weighing \< 40 kg.
* Patients with abnormal ECG indicative of acute or chronic ischemia or acute/chronic necrosis.
* Patients with anemias of any origin.
* Patients undergoing antibiotic treatment for acute infection.
* Patients with any blood abnormality.
* Patients with history of moderate to severe pancreatitis.
* A female subject who is breast-feeding, pregnant, intends to become pregnant or refuses to use a contraceptive method during the course of the study.
* Patients allergic to iodine or filgrastim.
* Patients using medications that could affect this study.
* Patients with serious mental conditions.
* Patients who have undergone a previous stem cell treatment.
* Patients who do not accept and sign the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT00971503
Study Brief:
Protocol Section:
NCT00971503