Skip to main content
OpenTrials
Completed

NCT Number: NCT00730561

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Limb Ischemia Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario "José E. González"

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hematopoietic stem cell transplantation

Biological

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 outcomes

  1. Change in nerve conduction velocity

    Time frame: Three months

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 8, 2008
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.