Status:
COMPLETED
Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Limb Ischemia
Diabetic Neuropathy
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineag...
Eligibility Criteria
Inclusion
- Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification.
Exclusion
- Patients older than 75 years
- Hypercoagulable states
- Cardiac ejection fraction \< 30%
- Active vasculopathy in brain, kidneys or heart
- Neoplastic disease
- Active infection
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Gangrene of the extremity requiring immediate surgery.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00730561
Start Date
March 1 2006
End Date
December 1 2007
Last Update
August 8 2008
Active Locations (1)
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1
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460