Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy - Full Text View

Sponsored by:	Hospital Universitario Dr. Jose E. Gonzalez
Information provided by:	Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:	NCT00730561

Purpose

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.

Condition	Intervention
Limb Ischemia Diabetic Neuropathy	Biological: Hematopoietic stem cell transplantation

MedlinePlus related topics: Diabetes Diabetic Nerve Problems

Drug Information available for: Filgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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.

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:

Change in nerve conduction velocity [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	March 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention
2: Experimental Hematopoietic stem cell transplantation	Biological: Hematopoietic stem cell transplantation Intramuscular application of CD34+ hematopoietic stem cells (with a minimum of 2 million CD34+ cells/kg) into the gastrocnemius muscles after stimulation with subcutaneous filgrastim 600 micrograms/kilogram a day for 4 days

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730561

Locations

Mexico, Nuevo León
Hospital Universitario "José E. González"
Monterrey, Nuevo León, Mexico, 64460

Sponsors and Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

Principal Investigator:

Fernando J Lavalle, MD

Departamento de Endocrinología del Hospital Universitario "José E. González"

More Information

Publications:

Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60.

Responsible Party:	Departamento de Endocrinologia ( Fernando Javier Lavalle Gonzalez )
Study ID Numbers:	Endo01
Study First Received:	July 31, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730561
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:

nerve conduction velocity
hematopoietic stem cell transplantation

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Ischemia
Diabetes Complications

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on February 05, 2009