ST266 Versus Standard Care In Treating Partial Thickness Burns

Burns Clinical Trial

Official title: Phase I/II Randomized Blinded Safety, Dose-determining Efficacy Trial Comparing Amnion-derived Cellular Cytokine Solution in 3 Different Regimens With Standard Care 0.9% Sodium Chloride in the Topical Treatment of Partial-thickness Burns

Status Terminated

Clinical Trial Summary

The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds. The trial will be a prospectively randomized and double-blind trial of ST266 compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.

Clinical Trial Description

A Phase I/II multi-center clinical trial will be performed in 99 adults with partial-thickness burns. Two similar partial-thickness burn areas in a single patient will be selected. One burn will be randomly assigned to receive either test drug ST266 or normal saline in one of three treatment regimens.

The three treatment arms will be:

1. ST266 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;

2. ST266 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and

3. ST266 0.01 mL/cm2 every other day vs. normal saline 0.01 mL/cm2 every other day.

Two different preclinical studies of partial-thickness burns on guinea pigs have demonstrated accelerated epithelialization with topical treatment with ST266. Similarly, preclinical studies in Yorkshire pigs have demonstrated more rapid maturity of epithelialization and better quality healing of partial-thickness skin graft donor sites with ST266 treatment.

In the preclinical studies, ST266 given in a dose of 0.01 mL/cm2 wound area appeared to saturate the wound adequately without excess and simultaneously improve healing. In preclinical toxicity studies, the dose of 0.01 mL/cm2 was shown to be safe. ;

Related Conditions & MeSH terms

• Burns

• NCT number: NCT00886470
• Study type: Interventional
• Source: Noveome Biotherapeutics, formerly Stemnion
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 2009
• Completion date: March 2010