NCT00886470

ST266 Versus Standard Care In Treating Partial Thickness Burns

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Burns

Interventions

Type	Name	Description
BIOLOGICAL	ST266	ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-04-23
• Last updated: 2019-05-15

Locations

14 sites across 1 country: United States