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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00730561
Other study ID # Endo01
Secondary ID
Status Completed
Phase N/A
First received July 31, 2008
Last updated August 7, 2008
Start date March 2006
Est. completion date December 2007

Study information

Verified date July 2008
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact n/a
Is FDA regulated No
Health authority Mexico: National Institute of Public Health, Health Secretariat
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Mexico Hospital Universitario "José E. González" Monterrey Nuevo León

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in nerve conduction velocity Three months No
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