Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center receives more than $31 million in federal funding to transform dental, oral, and craniofacial research into regenerative therapies

Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center leadership

The Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center is a multi-institute collaboration across the University of Michigan School of Dentistry, the University of Pittsburgh School of Dental Medicine, McGowan Institute for Regenerative Medicine, sciVelo, and Harvard University/Wyss Institute.

Funded by the National Institute of Dental and Craniofacial Research (NIDCR)*, the mission of the MPWRM Resource Center is to support translation of pre-clinical regenerative therapies for dental, oral, and craniofacial (DOC) tissues. Since its founding in 2017, the MPWRM Resource Center has been providing financial and advisory resources to translational projects in the field through its interdisciplinary network of clinical, engineering, regulatory and commercialization experts. The center has supported 19 interdisciplinary translational research projects that focus on development of regenerative therapies to address unmet needs in DOC tissues, including biologics, drug delivery, cellular therapies and medical devices. All 19 of these project teams have issued patents or filed patent applications, and 57% of the teams have had formal interactions with the FDA to refine strategies for regulatory clearance or approval for clinical applications.

The MPWRM Resource Center is led by a multidisciplinary Operating Committee that includes leaders of academic and industry research in tissue engineering and regenerative medicine with expertise in commercial translation and program management. At the University of Pittsburgh, the Operating Committee includes Charles Sfeir, DDS, PhD at the School of Dental Medicine’s Center for Craniofacial Regeneration (CCR), Donald P. Taylor, PhD, MBA, CLP, Executive Director of sciVelo and Assistant Vice Chancellor for Health Sciences Translation, and William R. Wagner, PhD at the McGowan Institute for Regenerative Medicine, who each contribute to the center by leveraging their expertise in translational and clinical research in addition to academic commercialization.

“The Resource Center reflects a key part of the McGowan Institute’s mission to develop technologies that address tissue and organ failure. We are very focused on not just the invention of solutions, but on moving these concepts forward to the patients in need. The Resource Center allows us to focus on the non-technical barriers to translation, such as regulatory guidance, appropriate pre-clinical testing or transition to regulated manufacturing. Our success in this partnership provides a model for translational approaches in other tissue areas as well.”

William R. Wagner, PhD, Director of McGowan Institute for Regenerative Medicine and Distinguished Professor of Surgery, Bioengineering and Chemical Engineering.

The School of Dental Medicine’s vision is to provide cutting edge therapies to its patients, and establishing the CCR is one part of this initiative.

“The strength of the CCR lies in the synergistic approach to translational research by clinicians, engineers and basic scientists. The environment at CCR fosters multidisciplinary approaches to regenerate mineralized and soft tissues of craniofacial structures and employ tissue engineered strategies such as cellular therapies, biomaterials and mechanobiology. Our innovation has resulted in new and unique technologies developed by the CCR members.”

Charles Sfeir, DDS, PhD, the Associate Dean for Research at the School of Dental Medicine, Associate Professor of Periodontics and Preventive Dentistry, Oral Biology and Bioengineering.

Four faculty members from the University of Pittsburgh’s CCR have received support from the MPWRM Resource Center, including Alejandro Almarza, PhD, Andrew Brown, PhD, Charles Sfeir, DDS, PhD and Juan Taboas, PhD, as well as two additional University of Pittsburgh faculty members, Steven Little, PhD at the Department of Chemical and Petroleum Engineering and Kacey G. Marra, PhD at the Department of Plastic Surgery.

One of the principle investigators, Dr. Alejandro Almarza, has developed a technology focused on temporomandibular joint (TMJ) disc repair by using extracellular matrix (ECM) scaffold as a device for the reconstruction of the TMJ.

“Patients who suffer from TMJ disc disease experience painful clicking and locking that can dramatically affect quality of life. Current therapies include joint replacement using alloplastic implants or autogenous grafts; however, long term outcomes with alloplastic implants are unclear, while autogenous grafts are associated with donor site morbidity. Our ECM-based device is designed to replace the meniscus of the TMJ by inducing the formation of new, patient-specific, functional tissue formation. Unlike currently available alloplastic implants, ECM-based device is biodegradable, and mimics the shape and size of native TMJ meniscus, without the need for autologous tissue harvesting.”
This device was patented in 2019 and validated in canine and porcine models. The group demonstrated that these ECM-based scaffolds can transform into fibrous cartilage tissue that exhibit similar biomechanical and biochemical properties with the actual TMJ disc and form near-normal tissues within a month post implantation.

“The MPWRM Resource Center has been instrumental in bridging the translation gap by providing resources to guide us through our communications with the FDA to obtain clarity on collection of animal data prior to the first in-human study. Furthermore, the MPWRM Resource Center is providing the funds to perform our last pre-clinical trial of the ECM device following the good manufacturing practices (GMPs) in an animal good laboratory practice (GLP) study. Traditional NIH funding mechanisms do not fund those types of studies as they are very expensive. Lastly, The MPWRM Resource Center has also been providing support to hone-in on market assessments for the technology, along with identifying commercial partners.”

Alejandro Almarza, PhD, Associate Professor of Oral Biology and Bioengineering, University of Pittsburgh.

In the spring of 2020, the MPWRM Resource Center has been awarded a $31.4 million stage 3 grant through the NIDCR of the National Institutes of Health to further support the important work of the Resource Center. The stage 3 funding will help projects like Dr. Almarza’s to move along their commercialization path after receiving the FDA approval. This path usually involves initiation of clinical trials in patients for validation of these technologies towards widespread clinical use to improve lives of patients. The goal of Dr. Almarza’s project is to create an off-the-shelf solution for TMJ disc disease.
Another exciting project led by Dr. Sfeir and Dr. Steve Little, the Chair of the Department of Chemical and Petroleum Engineering, aims to develop immunomodulatory strategies to treat periodontal disease. Periodontitis affects nearly half of adults over 30 in the U.S. If left untreated, dental implants and bone grafting procedures may be required. Antibiotics are currently used as an adjunct therapy to scaling and root planning, which remains the standard of care. With a shift away from antibiotics overuse, new treatment modalities that address the host immune response are needed. The team has developed controlled release systems that repair the underlying immunomodulation dysfunction responsible for tissue degeneration in periodontitis. These systems reduce inflammation and tissue destruction, and promote tissue regeneration through recruiting regulatory T cells or macrophages. The support from stage 3 funding will allow Dr. Sfeir and Dr. Little to develop this new exciting class of treatments, by delivering tiny amounts of proteins that are already found in the body and capable of influencing its own cells to repair the destructive inflammation resulting in periodontal disease.
Donald P. Taylor, PhD, MBA, CLP, the Executive Director of sciVelo, has been one of the founding architects of the MPWRM Resource Center since the stage 1 planning grant in 2015.
“sciVelo’s purpose in this stage 3 is to provide expert commercial translation guidance to each funded team in order to help them realize their goal of commercial implementation. We’ve been working to help build the project portfolio, making funding decisions, and aligning experimental design to market-oriented endpoints. We perform these functions here at Pitt and across the partner institutions which catalyzes a much larger community of business and science directed to dental, oral, and craniofacial innovation.”

Donald P. Taylor, PhD, MBA, CLP, the Executive Director of sciVelo, Assistant Vice Chancellor for Commercial Translation in the Health Sciences, and Associate Professor of Biomedical Informatics at the University of Pittsburgh.

Since its foundation, the Resource Center, with more than 70 experts involved, has supported 19 interdisciplinary translational projects to advance their research towards market implementation by offering comprehensive guidance in R&D, clinical and regulatory, as well as market and business development. Through this stage 3 grant, the Resource Center will help these projects move further to improve patient care by providing solutions for the unmet clinical problems in dental, oral, and craniofacial medicine.

*The MPWRM Resource Center is supported in part by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under Award Number U24DE026915.