NCT00730561CompletedNot Applicable
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.
Hospital Universitario Dr. Jose E. Gonzalez2 sites in 1 country20 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in nerve conduction velocity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in nerve conduction velocity
Time Frame: Three months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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