Bone Marrow Autotransplantation in Type 1 Diabetes
Not Applicable
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT00821899
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- diabetes type 1 patients
- 18 to 50 years of age
- more than 5 years of evolution of the disease
- brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes
Exclusion Criteria
- history of cancer
- hematologic alterations
- infectious disease positivity (HIV, HCV etc.)
- diabetic nephropathy
- cardiac failure
- liver disease
- autoimmune systemic disease
- allergy to iodine contrast or anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration. 12 months
- Secondary Outcome Measures
Name Time Method Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration. 12 months Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration. 12 months Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration. 12 months
Trial Locations
- Locations (2)
Enric Esmatjes
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain