MedTrace Logo

Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

NCT02130310 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2015-09-23

No results posted yet for this study

Summary

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.

Conditions

  • Chronic Venous Leg Ulcers

Interventions

BIOLOGICAL

CureXcell®

CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.

OTHER

Placebo injection

Normal saline injected at each centimeter of ulcer bed

Sponsors & Collaborators

  • Macrocure Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert Kirsner, MD, PhD · University of Miami

  • John Lantis, MD · St. Luke's-Roosevelt Hospital Center

  • Robert Snyder, DPM · Barry University Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02130310 on ClinicalTrials.gov