Lead investigator: Ellen Heber-Katz, PhD
Scars are an inescapable consequence of surgical wound healing because of normal processes of healing. For functional and cosmetic reasons, there is great interest in developing tools for non-scarring regeneration of normal tissue after a surgical procedure. While considerable effort has been dedicated to improving suturing and wound-healing strategies that reduce scarring, more effective approaches are still needed.
Basic research into the regenerative capabilities of amphibians and the MRL mouse strain that can regenerate lost appendages, where scars do not develop at the injury site as a result of epimorphic healing, have now led to the development of a novel suture formulation that limits scarring. This clinical device — informally referred to as HealSuture due to its deposition of a compound LIMR scientists have determined can promote epimorphic healing — offers an off-the-shelf modality to reprogram the capabilities of a tissue microenvironment, limiting the formation of scar tissue during the healing of surgical wounds.
HealSuture is a proprietary polylactic acid (PLA)-based suture infused with a compound that can promote regenerative healing and thereby limit scarring of a surgical wound. The technology is based on PLA sutures that dissolve during wound healing, thereby depositing the pro-regeneration compound at the wound site created by the surgical procedure. In essence, our approach locally restores a fetal program of stem cell-dependent processes of regenerative healing that avoids fibrotic deposition (scar tissue formation).
Using the suture as a depot for drug release, the active compound is released continuously into the local tissue over a 2-3 week period as the PLA suture dissolves. Varying doses released by different PLA suture preparations are envisioned to tailor treatments that maximize non-scarring healing of local wounds. This technology does not interfere with other methodologies that may be applied by surgeons to improve wound healing in particular settings, including to limit scar formation, infection risk or influence other metrics to promote optimal wound healing in a patient.
In summary, HealSuture offers an off-the-shelf clinical device to capture a latent capability for epimorphic healing, a non-scarring process of tissue regeneration suppressed in mammals after fetal development that can locally be re-activated by this technology.
To our knowledge, there is no dissolving suture technology that re-activates the natural latent process of epimorphic regenerative healing that is characteristic of fetal tissue at a surgical wound site. Unlike other technologies, the active compound deposited by HealSuture does not directly prevent scarring, but instead relieves suppression on a fetal pathway that reprograms local inflammatory and stem cell functions in the wound. The active compound in this technology was characterized extensively for its ability to promote regeneration in a variety of tissue types damaged by trauma, surgical resection, infection and age-related degeneration. Accordingly, HealSuture may have special utility to promote optimal healing of many types of surgical wounds.
HealSuture applications are based on preclinical studies suggesting that deposition of the active compound can promote regeneration of cartilage, nerve, bone, vasculature, muscle and organ tissues while limiting the formation of fibrotic tissue, the major constituent of wound scars. Thus, the suture technology is expected to be suitable for repairing surgical wounds, but also wounds caused by trauma, infection, normal or pathogenic tissue degeneration, and other types of wounds that require suturing. We envision broad, general applications in diverse tissue settings.
Stage of development
Preclinical genetic and therapeutic proof of concept in mice has been published for a first-generation drug-hydrogel formulation. The current stage of work focuses on a second-generation drug-hydrogel conjugate thought to represent a potential clinical lead agent. Data on deposition efficiency, time-course and drug clearance after wound suturing with HealSuture is under study.
PCT filed February 2020.
LIMR seeks partners to advance IND-enabling studies of the HealSuture as a unique clinical device for non-scarring regenerative healing of surgical wounds.
References and Publications
- Zhang Y, Strehin I, Bedelbaeva K, Gourevitch D, Clark L, Leferovich J, Messersmith PB and Heber-Katz E. Drug-induced regeneration in adult mice. Sci Transl Med 2015:7;290ra92.
- Cheng J, Amin D, Latona J, Heber-Katz E and Messerschmidt PB. Supramolecular polymer hydrogels for drug-induced tissue regeneration. ACS Nano 2019;13:5493-5.
- Nagai K, Ideguchi H, Kajikawa T, Li X, Chavakis T, Cheng J, Messersmith PB, Heber-Katz E, Hajishengallis G. An injectable hydrogel-formulated inhibitor of prolyl-4-hydroxylase promotes T regulatory cell recruitment and enhances alveolar bone regeneration during resolution of experimental periodontitis. FASEB J. 2020 Aug 19. doi: 10.1096/fj.202001248R.
Institutional contact: George C. Prendergast, PhD, LIMR President and CEO, 484.476.8475, [email protected]
L2C Partners contact: Merle Gilmore, 610.662.0940, [email protected]