Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy

Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2:A Randomized Controlled Trial.

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 lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.

Inclusion Criteria:

• 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 Criteria:

• 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.