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

Not Applicable

Completed

• Conditions: Limb Ischemia; Diabetic Neuropathy
• Interventions: Biological: Hematopoietic stem cell transplantation

• Registration Number: NCT00730561
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-07
• Last Update Submitted: 2008-08-07
• Study First Posted: 2008-08-08
• Last Update Posted: 2008-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Hematopoietic stem cell transplantation	Hematopoietic stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Change in nerve conduction velocity	Three months

Trial Locations

Locations (1)

Hospital Universitario "José E. González"; 🇲🇽 Monterrey, Nuevo León, Mexico