NCT00730561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

July 1, 2008

Enrollment Period

1.8 years

First QC Date

July 31, 2008

Last Update Submit

August 7, 2008

Conditions

Limb IschemiaDiabetic Neuropathy

Keywords

nerve conduction velocityhematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Change in nerve conduction velocity

    Three months

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

Hematopoietic stem cell transplantation

Biological: Hematopoietic stem cell transplantation

Interventions

Hematopoietic stem cell transplantationBIOLOGICAL

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

2

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "José E. González"

Monterrey, Nuevo León, 64460, Mexico

Location

Related 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. doi: 10.2337/diacare.28.9.2155.

    PMID: 16123483BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Fernando J Lavalle, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 8, 2008

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 8, 2008

Record last verified: 2008-07

Locations

ME(1)