BME Seminar: Kacey Marra
Monday, November 14th, 2022 - 12:00 p.m.
Kacey Marra, Ph.D.
Professor, University of Pittsburgh
Vice Chair of Research, Department of Plastic Surgery
"Clinical Translation of a Drug-Eluting Conduit for Nerve Repair"
Keating 103
Live Zoom Link | Passcode: BearDown
(Instructor permission required for enrolled students to attend via Zoom)
Hosts: Dr. Beth Hutchinson and Dr. Shang Song
Persons with a disability may request a reasonable accommodation by contacting the Disability Resource Center at 621-3268 (V/TTY).
ABSTRACT: Clinical translation of academic research can be particularly challenging. We have been developing a novel medical device to treat severe peripheral nerve injuries which are challenging to repair. For nerve injuries that result in gaps >2-3 cm, the standard of care is autografting; however, autografting can result in neuroma formation, loss of sensory function at the donor site, and increased operative time. Furthermore, autografting typically results in only 50-60% functional recovery. To address the need for an improved nerve conduit to treat large nerve gaps, we developed a biodegradable conduit comprised of poly (caprolactone) tube, with the walls of the conduit embedded with double-walled poly(lactic-co-glycolic acid)/poly(L-lactic acid), (PLGA)/(PLLA) microspheres encapsulating a neurotrophic protein Functional, electrophysiological and histological assessments demonstrated the efficacious bridging of a long peripheral nerve gap in a non-human primate 5-cm median nerve defect model. The pathway to clinical translation involves GMP manufacturing, sterilization, shipping, labeling, biocompatibility testing, mechanical testing, quality control, and then FDA approval. This talk describes the lessons learned from our 20-year journey from biomaterials fabrication and characterization, to in vitro cell studies, to small animal studies, to large animal studies, to GMP manufacturing and scale-up, and finally, submission to the FDA for the first-in-human clinical trial.
BIO: Dr. Kacey Marra is a professor in the Departments of Plastic Surgery (primary) and Bioengineering (secondary), as well as vice chair of research in the Department of Plastic Surgery, at the University of Pittsburgh. She is also a core faculty member of the McGowan Institute for Regenerative Medicine, where she has served as a member of the Executive Committee since 2004. She has a publication record of over 150 peer-reviewed articles, numerous patents, and over 650 abstracts in the areas of peripheral nerve repair, adipose stem cells, bioreactors, tissue engineering, wound healing, adipose stem cells, and diabetes. Her funding includes NIH, NSF, and DoD grants in the area of regenerative medicine. She was co-chair of the 2015 Tissue Engineering and Regenerative Medicine International Society (TERMIS) World Congress and was inducted as a Fellow of TERMIS in 2021. Dr. Marra is also the founder and CEO of Nerve Repair Technologies and is planning the first-in-human clinical trials with a tissue-engineered nerve guide.