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

H

Hospital Universitario Dr. Jose E. Gonzalez

Status

Completed

Conditions

Diabetic Neuropathy
Limb Ischemia

Treatments

Biological: Hematopoietic stem cell transplantation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

1
No Intervention group
2
Experimental group
Description:
Hematopoietic stem cell transplantation
Treatment:
Biological: Hematopoietic stem cell transplantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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