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

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez (Other)
• Overall Status: Completed
• CT.gov ID: NCT00730561
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in nerve conduction velocity [Three months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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"

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00730561
• Other Study ID Numbers: Endo01
• First Posted: Aug 8, 2008
• Last Update Posted: Aug 8, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: nerve conduction velocity; hematopoietic stem cell transplantation
• Additional relevant MeSH terms: Diabetic Neuropathies; Ischemia

Study Results

No Results Posted as of Aug 8, 2008