Celularity's Tri-Layer Amniotic Membrane Technology Reshapes Possibilities for Ocular Surface Reconstruction

Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, has unveiled groundbreaking research demonstrating how its proprietary tri-layer decellularized, dehydrated human amniotic membrane (DDHAM-3L) can serve as a transformative platform for treating ocular surface disorders. The peer-reviewed study, published on May 29, 2025, in Regenerative Engineering and Translational Medicine, marks a significant milestone in the convergence of stem cell science and advanced biomaterial engineering.

The Science Behind the Breakthrough

The collaborative research between Celularity and Dr. Jessica M. Gluck’s laboratory at North Carolina State University (NCSU) focused on a critical challenge in ophthalmology: limbal stem cell deficiency (LSCD), a condition where the eye’s regenerative capacity is compromised. The study evaluated how DDHAM-3L could support induced pluripotent stem cell (iPSC)-derived limbal stem cells (LSCs), which hold immense promise for restoring vision.

Over a seven-day laboratory investigation, iPSC-LSCs cultured on DDHAM-3L exhibited confluent cell sheet formation with typical epithelial characteristics. Remarkably, cells seeded on this biomaterial demonstrated accelerated proliferation rates compared to conventional control groups—a finding that underscores the material’s biocompatibility and biological functionality.

Evidence of Stemness and Regenerative Potential

Gene and protein expression profiling revealed upregulation of multiple markers linked to stemness, self-renewal capacity, and corneal epithelial differentiation pathways. These molecular signatures validate DDHAM-3L’s capacity as more than just a structural scaffold; the material actively supports the biological processes necessary for sustained regeneration.

Dr. Jessica M. Gluck, senior author of the research, emphasized that “DDHAM-3L provides a scalable, ready-to-use platform for ocular surface reconstruction while maintaining the biocompatibility essential for clinical translation.” This off-the-shelf characteristic addresses a long-standing limitation in regenerative medicine: the need for solutions that don’t require patient-specific customization yet maintain therapeutic efficacy.

Expanding Beyond Ophthalmology

Robert J. Hariri, M.D., Ph.D., CEO and Chairman of Celularity, highlighted that this technology extends far beyond treating eye disorders. The unique biological properties of DDHAM-3L position it as a versatile delivery system applicable across multiple regenerative medicine domains. By combining the scalability of iPSC technology with the robust performance characteristics of this advanced biomaterial, Celularity is creating a flexible platform for patient-specific cellular therapies.

The research validates that DDHAM-3L’s architecture and composition facilitate not only cell adhesion and proliferation but also preserve the critical stemness properties that enable long-term therapeutic benefit. This combination addresses two fundamental challenges that have historically limited cell therapy adoption: manufacturing consistency and therapeutic durability.

Clinical Translation and Industry Impact

For patients with LSCD and related ocular surface disorders, this advancement represents a potential shift toward more effective and accessible treatment options. The standardized nature of DDHAM-3L, derived from postpartum placental tissue, supports rapid clinical development and broader accessibility compared to approaches requiring extensive patient-specific preparation.

Celularity’s commitment to advancing this technology reflects the growing intersection of placental biology and regenerative medicine. By leveraging the postpartum placenta’s inherent biological advantages and natural availability, the company is pursuing solutions that address significant unmet global healthcare needs. The research published in this peer-reviewed venue reinforces the scientific foundation supporting such applications.

This development positions Celularity at the forefront of biomaterial innovation, where cellular medicine meets engineered solutions to restore function and improve patient outcomes across multiple therapeutic areas.