Celularity Announces Publication Advancing Ocular Surface Reconstruction with Tri-Layer Amniotic Membrane Technology
- Research demonstrates successful development of scalable, off-the-shelf solution for ocular surface reconstruction
- Study shows higher proliferation rates and improved cell performance using DDHAM-3L technology
- Technology has potential applications beyond ophthalmology in broader regenerative medicine field
- Publication in peer-reviewed journal validates the scientific merit of the technology
- None.
Insights
Celularity's tri-layer amniotic membrane shows promise as stem cell delivery system for eye surface disorders, expanding potential applications.
Celularity has achieved a significant scientific milestone with the publication of research validating their tri-layer decellularized, dehydrated human amniotic membrane (DDHAM-3L) technology in Regenerative Engineering and Translational Medicine. This peer-reviewed validation represents an important step in developing their regenerative medicine platform.
The collaborative research with North Carolina State University demonstrated that DDHAM-3L effectively supports induced pluripotent stem cell-derived limbal stem cells (iPSC-LSCs), which are critical for treating limbal stem cell deficiency (LSCD) and other ocular surface disorders. The in vitro study showed iPSC-LSCs on DDHAM-3L formed confluent cell sheets with higher proliferation rates compared to controls while maintaining markers of stemness and corneal epithelial commitment.
This represents a potential advancement in addressing ocular surface reconstruction challenges. Limbal stem cell deficiency, which can result from chemical burns, inflammatory conditions, and other injuries, often leads to vision impairment and has limited treatment options. The company's approach offers several advantages:
- Scalable, off-the-shelf solution potential
- Patient-specific cellular delivery system
- Preservation of stem cell characteristics
- Broader applications beyond ophthalmology
While this research demonstrates promising laboratory results, it's important to note this represents early-stage technology development. The pathway to clinical implementation, regulatory approval timelines, and commercialization strategy remain undefined in this announcement. The company will need to progress through preclinical testing and clinical trials before this technology could reach patients.
This publication bolsters Celularity's scientific credibility in regenerative medicine and expands their potential therapeutic applications beyond their existing pipeline, potentially opening new market opportunities in ophthalmology and other fields requiring advanced biomaterial scaffolds for cellular delivery.
Highlights the unique potential of Celularity’s proprietary advanced biomaterial technology as a novel cellular delivery system for ocular surface reconstruction
Supports broad range of regenerative medicine applications beyond ophthalmology
FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company, today announced its research published in the May 29, 2025, issue of the peer-reviewed journal Regenerative Engineering and Translational Medicine, a leading open-access journal publishing cutting-edge advances in regenerative medicine.
The full study titled "Tri-Layer Decellularized, Dehydrated Amniotic Membrane Supports Proliferation and Stemness of Limbal Stem Cells Derived from Pluripotent Stem Cells" demonstrates the potential of Celularity's proprietary tri-layer decellularized, dehydrated human amniotic membrane (DDHAM-3L) as an innovative carrier for induced pluripotent stem cell (iPSC)-derived limbal stem cells (LSCs) in treating limbal stem cell deficiency (LSCD) and other ocular surface disorders.
The research conducted in collaboration with Dr. Jessica M. Gluck’s team at North Carolina State University (NCSU) highlights DDHAM-3L’s ability to support the adhesion, proliferation, and stemness of iPSC-derived LSCs. “Our work unlocks a scalable, off-the-shelf solution for ocular surface reconstruction,” said Dr. Jessica M. Gluck, senior author of the study. “DDHAM-3L demonstrates its biocompatibility with LSCs and future utilization in the clinic.” Over a 7-day in vitro study, iPSC-LSCs seeded on DDHAM-3L formed confluent cell sheets, exhibited epithelial morphology, and demonstrated a higher proliferation rate compared to controls. Gene and protein expression analyses further confirmed the upregulation of markers associated with stemness, self-renewal, and corneal epithelial commitment, underscoring DDHAM-3L’s potential as an advanced biomaterial for ocular surface reconstruction.
“This collaborative research work with Dr. Gluck’s team at NCSU marks a significant step forward in addressing the challenges of treating LSCD and other ocular surface disorders,” said Robert J. Hariri, M.D., Ph.D., a publication coauthor and Celularity CEO and Chairman. “Our DDHAM-3L technology, with its unique biological properties, offers a promising platform for delivering patient-specific, iPSC-derived LSCs to restore vision and improve patient outcomes. This also supports broader applications of this biomaterial technology beyond ophthalmology.”
Celularity is committed to advancing this technology in a broad range of clinical applications, leveraging the scalability and patient-specific benefits of iPSC-derived LSCs combined with the robust performance of DDHAM-3L. This innovation has the potential to transform the treatment landscape for ocular surface disorders, providing a reliable and effective solution for patients worldwide.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com.
Forward Looking Statements
This press release includes “forward-looking statements” (as defined under Federal securities laws). These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
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