Overview
Regenerative Wound Dressing for Improved Healing in Space
Principal Investigator:
Abram D. Janis
Organization:
ACell, Inc.
Technical Summary
Lacerations and abrasions are common in spaceflight, due to restricted quarters, high activity levels and interaction of the cutaneous tissues with Extravehicular Mobility Units (EMU). Wound healing of cutaneous tissue is a complex, orchestrated process involving the interaction of soluble factors, extracellular matrix (ECM), inflammatory cells, and tissue-specific cells. In space, conditions of microgravity and low oxygen tension affect the normal wound healing process. Specifically, conditions of microgravity have been shown to decrease the cellular response to growth factors, and reduced oxygen tension is known to delay healing and increase protease levels.
ACell, Inc. (Columbia, MD) has developed and currently markets MatriStem® porcine urinary bladder matrix (UBM), an ECM-derived biomaterial in lyophilized sheet, multilaminate sheet, and micronized powder forms. UBM contains native tissue components including collagens, glycosaminoglycans, and growth factors, which are released as the material is broken down in the wound. The degradation products of UBM have also been demonstrated to have antimicrobial activity in vitro. MatriStem wound dressings have shown efficacy in chronic wound healing, however the current forms would be difficult to apply in a low gravity environment.
Specific Aims
1) Develop a novel MatriStem UBM gel formulation which can be easily administered to wounds in space;
2) characterize and screen the composition and bioactivity of candidate UBM gels in vitro using enzyme-linked immuosorbent assays (ELISA's), viscous properties, and cell culture;
3) test the vulnerary properties of the most promising UBM gels in vivo in an accepted model of compromised wound healing;
4) perform biocompatibility testing of the most effective gel from the animal study per ISO 10993; and,
5) verify and validate the product following design controls per 21 CFR 58. These activities will support the submission of a 510(k) application for FDA clearance of the MatriStem gel formulation at the end of the proposed 12-month SBRI/ACell joint project and will result in a novel, U.S. Food and Drug Administration (FDA)-cleared wound dressing that will both meet the demands of wound care in space and benefit the more than 6.5 million American patients afflicted with chronic wounds.
ACell, Inc. (Columbia, MD) has developed and currently markets MatriStem® porcine urinary bladder matrix (UBM), an ECM-derived biomaterial in lyophilized sheet, multilaminate sheet, and micronized powder forms. UBM contains native tissue components including collagens, glycosaminoglycans, and growth factors, which are released as the material is broken down in the wound. The degradation products of UBM have also been demonstrated to have antimicrobial activity in vitro. MatriStem wound dressings have shown efficacy in chronic wound healing, however the current forms would be difficult to apply in a low gravity environment.
Specific Aims
1) Develop a novel MatriStem UBM gel formulation which can be easily administered to wounds in space;
2) characterize and screen the composition and bioactivity of candidate UBM gels in vitro using enzyme-linked immuosorbent assays (ELISA's), viscous properties, and cell culture;
3) test the vulnerary properties of the most promising UBM gels in vivo in an accepted model of compromised wound healing;
4) perform biocompatibility testing of the most effective gel from the animal study per ISO 10993; and,
5) verify and validate the product following design controls per 21 CFR 58. These activities will support the submission of a 510(k) application for FDA clearance of the MatriStem gel formulation at the end of the proposed 12-month SBRI/ACell joint project and will result in a novel, U.S. Food and Drug Administration (FDA)-cleared wound dressing that will both meet the demands of wound care in space and benefit the more than 6.5 million American patients afflicted with chronic wounds.
Earth Applications
It has been estimated that 1-2% of the population in developed countries will suffer from a chronic wound in their lifetime . The United States is the world’s largest and fastest growing chronic wound care market. Currently, over 6.5 million Americans are afflicted with these wounds.
MatriStem in sheet and powder forms is currently FDA cleared for a variety of wound indications and is in clinical use today. A UBM gel formulation will improve performance by easing controlled delivery to tunneling chronic wounds, and may improve performance through better approximation of uneven wound surfaces with the dressing. The powder offers a higher surface area to volume ratio than the sheet form; a gel would further increase the contact of injured soft tissue with the gel formulation and could also be used to smooth a wound bed that was unsuitable for grafting due to its uneven surface.
Based on the success of powder and sheet forms of MatriStem in these cases, there is a high level of confidence in improved performance of a bioactive gel dressing. The gel UBM would also be beneficial in other wounds currently treated with MatriStem: surgical wounds, abrasions, trauma, post-Moh’s wounds, and burns. This type of product could additionally reduce health care costs by decreasing the length of hospital stays and number of visits to wound care clinics.
MatriStem in sheet and powder forms is currently FDA cleared for a variety of wound indications and is in clinical use today. A UBM gel formulation will improve performance by easing controlled delivery to tunneling chronic wounds, and may improve performance through better approximation of uneven wound surfaces with the dressing. The powder offers a higher surface area to volume ratio than the sheet form; a gel would further increase the contact of injured soft tissue with the gel formulation and could also be used to smooth a wound bed that was unsuitable for grafting due to its uneven surface.
Based on the success of powder and sheet forms of MatriStem in these cases, there is a high level of confidence in improved performance of a bioactive gel dressing. The gel UBM would also be beneficial in other wounds currently treated with MatriStem: surgical wounds, abrasions, trauma, post-Moh’s wounds, and burns. This type of product could additionally reduce health care costs by decreasing the length of hospital stays and number of visits to wound care clinics.