Category: C-DOCTOR News

The Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) has published a new article “Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC): An Infrastructure for Accelerating Regenerative Therapies from Discovery to Clinical Impact” in the Journal of Clinical and Translational Science outlining its infrastructure for accelerating regenerative therapies from discovery to clinical impact. The paper highlights how DOCTRC integrates multidisciplinary expertise, translational research resources, and collaborative networks to advance innovative therapies in dental, oral, and craniofacial health. Read the full article here: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/article/dental-oral-and-craniofacial-tissue-regeneration-consortium-doctrc-an-infrastructure-for-accelerating-regenerative-therapies-from-discovery-to-clinical-impact/483B924AB0F26A8B1554A9A4ED66FCD8  

The Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC) is a national initiative established in 2017  from the National Institute of Dental and Craniofacial Research (NIDCR) to advance regenerative therapies from preclinical development to clinical adoption. The 6th Annual DOCTRC Joint Retreat was held December 9–10, 2025, at the USC Health Sciences Conference Center in Los Angeles, CA, and was jointly hosted by the Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR) and the Translational Resource Center (TRC). The retreat brought together interdisciplinary translational project (ITP) teams across the DOCTRC portfolio, along with consortium leadership, external advisors, invited experts, and NIH/NIDCR program officials. The meeting focused on fostering collaboration while highlighting progress toward preclinical milestones, regulatory readiness, and commercialization of novel dental, oral, and craniofacial therapies. Supported by NIDCR through NIH Awards U24DE029462 and U24DE029463, DOCTRC maintains a diverse portfolio of ITPs spanning soft tissue regeneration, bone repair, dental pulp regeneration, nerve repair, and salivary gland restoration. Projects across the portfolio are advancing along IND, IDE, and 510(k) regulatory pathways, underscoring the consortium’s commitment to translational rigor and FDA engagement. The retreat program featured several expert-led sessions focused on commercialization and regulatory strategy. The workshop “Milestones & Mindsets Across the Founder Journey” was led by Rosemary Kiser, PhD, Tariq Warsi, PhD, Harriet Posner, JD, Gila Jones, JD, Robby Lane, MBA, and Chelsea Bahney, PhD, and addressed key challenges in product development, entrepreneurship, and company formation. The session “Science, Startups, and Success” had presentations by Thomas Chen, MD, PhD, and Zhen Xu, PhD, and breakout discussions highlighting pathways for translating scientific discovery into successful startups. A dedicated regulatory session titled “FDA Phase-Out of Animal Testing Requirements” was presented by Erika Fernandez, BPharm, MSc, RAC, providing timely insights into evolving FDA expectations and their impact on translational research strategies. Across two days, ITP presentations, networking events, and structured discussions enabled direct feedback between project teams, DOCTRC leadership, and NIDCR staff. Closed-door discussions among DOCTRC leadership, the External Advisory Board, and NIH representatives supported strategic planning for the next phase of the consortium and alignment of current project needs with future expansion opportunities. Through the 6th Annual Joint Retreat, DOCTRC reaffirmed its mission to accelerate innovative regenerative therapies toward clinical translation and broad adoption, while strengthening collaboration across its interdisciplinary translational ecosystem.

Hydronovo, Inc. has been awarded a $1.04 million SBIR/STTR Award from the National Institute of Dental and Craniofacial Research (NIDCR) for the project titled “Regeneration of radiation-damaged salivary glands using neurogenic stimulation of stem cells.” Led by Chelsea Bahney, PhD, and Sarah Knox, PhD, the project addresses xerostomia (chronic dry mouth), a condition that affects up to one in four adults over age 50 and commonly results from radiation therapy for head and neck cancer, autoimmune disease, or aging. Current treatments are largely palliative and fail to restore salivary gland function. Hydronovo’s investigational therapy, Ceviginate (CVGN8), is an injectable neuromimetic hydrogel designed to regenerate salivary glands by reactivating stem cells and restoring their secretory function. With FDA guidance and prior NIH and CIRM support, Hydronovo will use this award to complete IND-enabling studies, including large-animal safety testing, packaging development, and shelf-life testing—key steps toward first-in-human clinical trials. Hydronovo’s mission is to pioneer regenerative therapies that restore communication between nerves and organ-specific stem cells, offering new hope to patients living with xerostomia.

C-DOCTOR, the Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration, is a resource center aimed at accelerating promising tissue engineering/regenerative medicine therapies to broad clinical adoption. C-DOCTOR hosted the 2025 C-DOCTOR Spring Retreat took place on April 14–15, 2025, at the UCLA Meyer & Renee Luskin Conference Center in Los Angeles, CA. This retreat served as an excellent opportunity for attendees to connect and collaborate with other project teams, external advisors and consultants, as well as the C-DOCTOR leadership and NIDCR program staff. C-DOCTOR is supported by the National Institutes of Dental and Craniofacial Research, National Institutes of Health Award: U24DE029463. C-DOCTOR maintains a portfolio of eight interdisciplinary Translational Projects (ITP) teams working toward completing pre-clinical product development and FDA product clearance. One of these teams has recently achieved a successful IND filing and is actively working towards funding for clinical trials. Several other ITPs have had FDA interactions and will soon file IND/IDE packages. The event showcased the advancement of projects within C-DOCTOR’s ITP portfolio. C-DOCTOR celebrated significant ITP milestones: FDA interactions, commercialization/entrepreneurial progress, and fundraising for clinical trials. The 2025 C-DOCTOR retreat also featured sessions for ITP networking and for planning C-DOCTOR’s expansion beyond tissue engineering/regenerative medicine therapies in the dental, oral, and craniofacial space. C-DOCTOR and Looking Ahead C-DOCTOR begins to explore avenues to scale and expand its infrastructure for applications beyond tissue engineering in the DOC space (e.g., wearable sensors, diagnostics, implantables) and beyond the DOC space (e.g., neuromuscoskeletal system, glandular system). Invited speakers provided brief overviews of their projects or departmental/institutional capabilities to provide the foundation for scoping discussions to shape the future direction of C-DOCTOR. Attendees gained insights into emerging opportunities and shared insights for expanding the impact of C-DOCTOR Attendees also participated in breakout discussion sessions to further strategize on how to best position C-DOCTOR to address current and anticipated ITP needs as well as how to balance these needs with planned expansion opportunities. ITPs were able to provide feedback and communicate directly with C-DOCTOR leadership and NIDCR program staff. ITP Poster Session ITP teams participated in a poster session designed to foster collaboration with other teams and retreat attendees, including C-DOCTOR leadership, staff, and guests, while addressing questions related to their projects. The session provided a platform for teams to receive valuable feedback and insights. It also encouraged cross-team learning and sparked new ideas for advancing project goals.

Registration and Hotel: https://tiny.ucsf.edu/2025CDOCTORretreat

Dr. Chelsea Bahney, an Associate Professor in the UCSF Department of Orthopaedic Surgery and C-DOCTOR PI, was recently featured as a ‘UCSF Frontline Innovator’ at the UCSF Innovation Showcase during the JP Morgan Conference on January 13-16, 2025. This event spotlighted pioneering healthcare innovations from university-founded companies. Dr. Bahney, alongside her colleague Dr. Sarah Knox, presented on behalf of Hydronovo, a start-up dedicated to advancing tissue regeneration through stem cell reactivation. Their presentation emphasized ongoing research aimed at addressing salivary gland dysfunction, supported by funding from the National Institute of Dental and Craniofacial Research (NIDCR), the C-DOCTOR Program, and the California Institute for Regenerative Medicine (CIRM). It was a great event to be showcased in, providing an exciting platform to highlight groundbreaking regenerative research. We look forward to building on this momentum and seeing great things emerge in the future.

In October 2024, C-DOCTOR PI Dr. Derrick Wan was honored with the Shils Excellence in Research Award for his innovative project titled “Transdermal Deferoxamine for Treatment of Irradiated Soft Tissue.” This project focuses on using deferoxamine, administered through the skin, to aid in healing damaged soft tissue caused by radiation. Around one-third to one-half of cancer patients receiving radiation therapy suffer from severe soft tissue injury, with current treatments offering limited solutions. Dr. Derrick Wan has developed using a transdermal patch delivery system for deferoxamine. Preclinical studies have shown that direct injection of deferoxamine improves blood flow and tissue quality in irradiated areas, but this method poses logistical challenges. The transdermal patch offers a more patient-friendly and efficient treatment, addressing a significant clinical need for better management of radiation-induced fibrosis. Dr. Derrick Wan was honored with the Shils Excellence in Research Award in 2024 for his work in developing this novel and innovative approach. The nonprofit organization Dr. Edward B. Shils Entrepreneurial Fund honors the legacy of Dr. Shils and promotes entrepreneurship and leadership in oral health through its support of award programs that recognize individuals and organizations making significant contributions to public health and oral care. Other awards include the Shils-Meskin Award for outstanding contributions to dentistry, the Cohen-Volpe Award for healthcare innovation, and others for excellence in industry, community service, academic research, and special recognition for impacts on the dental community. In 2023, the recipient of the Excellence in Research was Acting Director of the NIDCR, Jennifer Webster-Cyriaque. We congratulate Dr. Wan for this well-deserved achievement.

On January 1, 2024, Dr. Geoffrey Gurtner received the Flinn Foundation Bioscience Entrepreneurship Program award. This Arizona biotech funding agency focuses on helping new Arizona technologies accelerate commercialization of new clinical treatments for patients. The award ($100K) will be used to for drug product manufacturing of Kinase Inhibitors ahead of their planned clinical trial for Dr. Gurtner’s ITP “Prevention of Scar Formation in the Skin Using Topical Focal Adhesion Kinase Inhibitors (Click here to read more about his project.)

The 2024 C-DOCTOR Spring Retreat was hosted at the Residence Inn by Marriott at Berkeley, CA on June 3–4, 2024. The Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) is comprised of nine Interdisciplinary Translational Projects (ITP) teams, one having a recent successful IND filing and making efforts to begin a first-in human trial. This year’s C-DOCTOR retreat was supported in part by the California Institute for Regenerative Medicine (CIRM) through conference grant: EDUC1-16388. The retreat was an excellent opportunity for attendees to connect with other project teams, the C-DOCTOR leadership, and external advisors and consultants to network and collaborate. The event highlighted the progress of the projects in C-DOCTOR’s ITP portfolio. C-DOCTOR celebrated the progress of its ITPs with five ITP teams with eight FDA interactions (e.g., IND submission, Pre-Submissions and clarification teleconferences, and Requests for Designation). In addition to updates from the ITP teams, the retreat featured a variety of sessions and panels to demonstrate C-DOCTOR’s progress to date and opportunities to grow in the future. A summary of the sessions is below. CIRM Presentation Lisa Kadyk, PhD (Associate Director of Therapeutics Development) gave a presentation about CIRM’s mission, goals, and funding source; the different grant mechanisms available through CIRM; and non-grant resources available through or associated with CIRM. Sensors and Wearable Diagnostics Session: Clinical Applications and Use Cases in the DOC Space and their Role in Tissue Regeneration Geoffrey Gurtner, MD and Uttam Sinha, MD, gave presentations on the development of sensors or wearable diagnostics products and their clinical applications. Dr. Gurtner presented on the development of his smart bandage (Click here to read more). Dr. Sinha presented on his SaliSense technology aimed at early detection of head and neck cancer. These presentations served as the baseline for discussion to explore the role of these products in the future direction of the C-DOCTOR program. Best Practices for FDA Interactions Focusing on IND/IDE-Enabling Data: Experts from CDRH and CBER Srinivas Nandkumar, PhD, Adam Chin, PhD, Sherrill Lathrop Blitzer, PhD (FDA CDRH), and Mondona McCann, PhD (FDA CBER) presented on best practices for FDA interactions with a focus on IND/IDE-enabling data such as determining appropriate animal models, preparing data for the FDA, as well as common challenges/pitfalls during FDA interactions and how to avoid them. This session was timely as more ITPs in the C-DOCTOR portfolio plan for FDA interactions in the upcoming year in the form of full IND/IDE submissions, Pre-Submissions, and Requests for Designations. Bridging Academic Regulatory Science Centers and C-DOCTOR for Enhanced Regulatory Science Practice and Training Kathy Giacomini, PhD, BSPharm and Eunjoo Pacifici, PharmD, PhD presented on the  UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) and the training programs available at the USC School of Pharmacy’s Department of Regulatory and Quality Sciences. They provided discussion on how C-DOCTOR can create further collaborations with organizations like the FDA and improve internal C-DOCTOR practices. C-DOCTOR and Looking Ahead: Integrative Health Helene Langevin, MD presented on the mission and current initiatives at NIH RE-JOIN and provided an overview of musculoskeletal integrative health. Her presentation served as a springboard for how to understand and leverage mutual synergies between C-DOCTOR, NIDCR, and other NIH institutes.   C-DOCTOR receives funding from the National Institute of Dental and Craniofacial Research (NIDCR; award: U24DE029463) with the mission to shepherd new therapies through pre-clinical studies and into human clinical trials, commercialization, and broad clinical adoption. As C-DOCTOR enters year 5 of its funding cycle, it looks forward to achieving continued success with more IND/IDE filings and more FDA interactions. In addition, C-DOCTOR poises itself to be at the forefront of product development and innovation in tissue engineering/regenerative medicine in the dental, oral, and craniofacial field and beyond.

C-DOCTOR ITP PI, Geoffrey Gurtner (Chair, University of Arizona, Department of Surgery) was recently featured on NPR’s Morning Edition and The Wall Street Journal discussing the development of his “smart bandage”. He is developing this product in collaboration with Stanford University and with funding from the Department of Defense. This “smart bandage” senses impending infections and delivers electrical pulses to treat them. The aim of this technology is to aid field medics in treating wounded soldiers on the battlefield. Beyond military applications, smart bandages could eventually diagnose and treat postoperative infections, with the first generation expected on the market in two to three years. With ongoing advancements, smart bandages promise to revolutionize wound care, offering advanced, real-time treatments that improve patient outcomes and save lives. Though this product differs from the one being developed as part of his Scar Formation Prevention ITP, C-DOCTOR celebrates Dr. Gurtner’s translational research efforts to develop innovative products to address wound healing. Click here to read more on this technology.