Ongoing Clinical Research - Applied Tissue Technologies

CLINICAL STUDIES

Phase II Enhancement. Clinical Case Series for NPWT treatment with PWD.

$420k. In process.This effort will investigate 10 patients with incisional wounds to study the safety and efficacy of the PWD’s negative pressure wound therapy function.

“The Utilization of a Novel Wound Chamber for the Treatment of Ocular Injuries and Infections Including Periocular Burns at the Institute of Surgical Research”.

Clinical Study. This is an intramural project, that will enroll approximately 60 patients in a randomized, controlled, prospective clinical trial. We have a CRADA with the USAISR Ocular Trauma Group. In Process.

“Prolonged Field Care with Platform Wound Device”.

Sponsor USAMRAA $2.9 million. Clinical Study. Contract number W81XWH-18-2-0002. In process. This clinical study will enroll 94 patients in a randomized, controlled, prospective clinical trial that will be broken into 2 major categories. Injuries to the limbs where a full limb PWD will be placed on the patient and commercially available Gentamicin cream administered as a prophylactic antibiotic. In the second group commercially available lidocaine gel will be administered to hand injuries contained within the PWD and compared to enclosing the wound within the PWD alone.

PRECLINICAL STUDIES

“Development of Technologies that Address the Complex Architecture of the Face During the Treatment of Severe Facial Burn Injury”.

SBIR funding sponsored by USAMRAA $1.150 million. Preclinical study. Contract number W81XWH-14-C-0015. Phase I and II Completed.

“A New Platform for Burn Treatment and for Delayed Evacuation of Service Members”.

Funding sponsored by MBRP-BIRA $2 million. Preclinical Study. Contract number W81XWH-16-1-0784. In process. Dr. Eriksson is the PI on this award and The Metis Foundation is the prime. The research is focused on the topical drug delivery capabilities of the PWD, development of a proprietary hydrogel, and a study of competitive negative pressure wound therapy systems in head to head safety and efficacy model vs. the PWD in a GLP swine model.

“ReFacE (Restoration of the Functional Aesthetic Craniofacial Envelope and Extremities)”. Regeneration.

Sponsor USAMRAA $2.9 million. Preclinical Study. BA170661. Under contracting negotiations. Expected start date January 1, 2019. In this preclinical effort a consortium of thought leaders in regenerative medicine have been assembled to study the efficacy of using the PWD to study adipose grafting, inflammation, and pixel skin grafting. Dr. Eriksson as PI will lead teams from the ISR, Northwestern, Applied Tissue and Pittsburgh. The Metis Foundation will be the Prime for this consortium.