Status:
WITHDRAWN
Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes
Lead Sponsor:
University of Moron
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00971503
Start Date
February 1 2011
End Date
February 1 2012
Last Update
July 27 2011
Active Locations (1)
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1
School of Medicine, Pontificia Universidad Catolica de Chile
Santiago, Santiago de Chile, Chile