MedTrace Logo

Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

NCT00665145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-11-01

No results posted yet for this study

Summary

The primary and secondary objectives of this study are:

Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells circulating in peripheral blood.

Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory testing (QST)

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Diabetic Polyneuropathy

Interventions

DRUG

SB-509

Active drug

DRUG

SB-509

Active drug

DRUG

Placebo

Placebo

DRUG

SB-509

Active drug

Sponsors & Collaborators

  • Sangamo Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665145 on ClinicalTrials.gov