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

NCT ID: NCT00730561

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Limb Ischemia Diabetic Neuropathy

Keywords

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nerve conduction velocity hematopoietic stem cell transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Hematopoietic stem cell transplantation

Group Type EXPERIMENTAL

Hematopoietic stem cell transplantation

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role lead

Responsible Party

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Departamento de Endocrinologia

Principal Investigators

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Fernando J Lavalle, MD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Endocrinología del Hospital Universitario "José E. González"

Locations

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Hospital Universitario "José E. González"

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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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. doi: 10.2337/diacare.28.9.2155.

Reference Type BACKGROUND
PMID: 16123483 (View on PubMed)

Other Identifiers

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Endo01

Identifier Type: -

Identifier Source: org_study_id