search
Back to results

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

Primary Purpose

Limb Ischemia, Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Hematopoietic stem cell transplantation
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limb Ischemia focused on measuring nerve conduction velocity, hematopoietic stem cell transplantation

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario "José E. González"

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Hematopoietic stem cell transplantation

Outcomes

Primary Outcome Measures

Change in nerve conduction velocity

Secondary Outcome Measures

Full Information

First Posted
July 31, 2008
Last Updated
August 7, 2008
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
search

1. Study Identification

Unique Protocol Identification Number
NCT00730561
Brief Title
Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Ischemia, Diabetic Neuropathy
Keywords
nerve conduction velocity, hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Hematopoietic stem cell transplantation
Intervention Type
Biological
Intervention Name(s)
Hematopoietic stem cell transplantation
Intervention Description
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 Outcome Measure Information:
Title
Change in nerve conduction velocity
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando J Lavalle, MD
Organizational Affiliation
Departamento de Endocrinología del Hospital Universitario "José E. González"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "José E. González"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16123483
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs