ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00730561
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Limb Ischemia Diabetic Neuropathy Biological: Hematopoietic stem cell transplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1
Experimental: 2
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




Primary Outcome Measures :
  1. Change in nerve conduction velocity [ Time Frame: Three months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730561


Locations
Mexico
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"

Publications:
Responsible Party: Fernando Javier Lavalle Gonzalez, Departamento de Endocrinologia
ClinicalTrials.gov Identifier: NCT00730561     History of Changes
Other Study ID Numbers: Endo01
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: July 2008

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
nerve conduction velocity
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Ischemia
Diabetic Neuropathies
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases