Celularity’s Tri-layer Decellularized, Dehydrated Human Amniotic Membrane Product Investigated as a Carrier of Induced Pluripotent Stem Cell Derived-Limbal Stem Cells in the Treatment of Severe Ocular Surface Disease

FLORHAM PARK, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) — Celularity Inc. (Nasdaq: CELU) (“Celularity”) a biotechnology company developing allogeneic cell therapies and advanced biomaterial products, today announced that its abstract “Tri-layer decellularized, dehydrated human amniotic membrane supports proliferation and stemness of limbal stem cells derived from induced pluripotent stem cells” has been accepted as a poster presentation at WBC 2024, the 12th World Biomaterials Congress which will be held on 26-31 May 2024 in Daegu, Republic of Korea, and hosted by the Korean Society for Biomaterials (KSBM). The theme of WBC 2024 is “Convergence in Biomaterials: a vision for the future of healthcare.”

The study described in the poster presentation investigated Celularity’s tri-layer decellularized, dehydrated human amniotic membrane technology product as a carrier of induced pluripotent stem cell derived-limbal stem cells (iPSC-LSC) which were investigated for the treatment of limbal stem cell deficiency (LSCD). LSCD is a debilitating ocular surface disorder that occurs due to loss or dysfunction of limbal stem cells (LSCs) that are vital for the re-population of the corneal epithelium and to the barrier function of the limbus. Limbal Stem Cell (LSC) transplant is a recognized method to restore the ocular surface in advanced stem cell deficient corneas.

Robert J. Hariri, M.D., Ph.D., Celularity Chairman, CEO and Founder, noted, “LSCD is characterized by cellular invasion onto the cornea by conjunctival epithelium, leading to impaired epithelial wound healing and resulting in chronic ocular surface inflammation, neovascularization, and eventually opacification. The causes of LSCD include trauma and contact lens wear as well as infection and inflammation and this represents a significant clinical opportunity for Celularity’s regenerative medicine technologies.” According to data published by Delve Insight, the United States had the highest number of diagnosed prevalent cases of LSCD.

Anna Gosiewska, PhD., Vice President of Research and Development for Degenerative Diseases, leading Celularity’s development of advanced biomaterials and cell technologies, stated, “The investigation into the integration of placental biomaterials into regenerative cellular medicine protocols may enhance the efficacy of stem cell therapies expanding the scope of potential applications, from treating degenerative diseases to repairing damaged tissues and organs. As our research continues to explore the remarkable capabilities of placental biomaterials combined with cell-based technologies, we believe we can accelerate the translation of discoveries from the laboratory to the clinic, bringing our innovative solutions to patients.”

The Gluck Tissue Engineering Laboratory is part of the Wilson College of Textiles at North Carolina State University and is focused on understanding how the microenvironment contributes to stem cell differentiation and function. Its Tissue Engineering Lab Team is particularly interested in corneal tissue engineering, focusing primarily on ocular surface regeneration. As noted by Dr Jessica M. Gluck, Principal Investigator of the Gluck Lab, “Working with Celularity provides a collaborative effort of moving ocular regenerative medicine closer to the clinic.”

The study described in the poster presentation concluded that tri-layer decellularized, dehydrated human amniotic membranes have the potential to be a viable carrier for iPSC-LSCs for the treatment of LSCD and other ocular surface disorders. The off-the-shelf availability of existing commercial tri-layer decellularized, dehydrated human amniotic membrane products, in combination with iPSC-LSCs, may improve patient access to LSCD treatment and the therapeutic management of LSCD.

The abstract authors are Nasif Mahmood (principal author), Daxian Zha, Dr. Brain C. Gilger, and Dr. Jessica M. Gluck, all of North Carolina State University; and Dr. Anna Gosiewska, Dr. Stephen A. Brigido, Dr. Robert J. Hariri, all of Celularity.

About Celularity

Celularity is a cellular and regenerative medicine company developing “off-the-shelf” placental-derived allogeneic cellular therapy product candidates, including T cells engineered with a chimeric antigen receptor (“CAR”), unmodified natural killer (“NK”) cells and genetically modified CAR NK cells, and mesenchymal-like adherent stromal cells (“MLASCs”). These therapeutic candidates target indications across a range of degenerative disorders and diseases including those associated with aging, which is known to be a major risk factor across multiple therapeutic areas including cancer, regenerative medicine, and immune disorders. Celularity also develops, manufactures, and markets advanced biomaterial products derived from the postpartum placenta and the umbilical cord and operates a commercial biobanking service. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it is able to develop solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

For more information, visit www.celularity.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include statements regarding: (i) the efficacy of a combination product which includes tri-layer decellularized, dehydrated human amniotic membrane and iPSC-LSCs; and (ii) the potential for Celularity’s tri-layer decellularized, dehydrated human amniotic membrane to be a viable carrier for iPSC-LSCs for the treatment of LSCD and other ocular surface disorders .

Forward-looking statements include all statements that are not historical facts and all statements relating to future events, including expectations regarding our operational and efficiency initiatives, our strategy, expected net revenue per unit, forecasted results, and expectations regarding the effect of our actions to improve performance. These forward-looking statements reflect our current expectations and projections with respect to, among other things, the Company’s financial condition, results of operations, plans, objectives, strategy, future performance, and business. In some cases, you can identify forward-looking statements by terminology that may precede, follow or include the words “aim,” “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “likely,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “project,” “projection,” “seek,” “should,” “strive,” “target,” “will,” “would,” “will,” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning.

The forward-looking statements in this press release are subject to risks and uncertainties and we caution against placing undue reliance on such statements. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: statements regarding our ability to develop a combination product which includes tri-layer decellularized, dehydrated human amniotic membrane and iPSC-LSCs; regulatory uncertainties associated with the use of tri-layer decellularized, dehydrated human amniotic membrane in combination with iPSC-LSCs; our ability to expand the scope of potential applications of stem cell therapies; and the risks associated with our current liquidity, along with those risk factors set forth under the caption “Risk Factors” in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, 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 we do not presently know, or that we currently believe 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 our 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 our views as of any subsequent date, and we undertake no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Celularity Investor Contact: 

Carlos Ramirez, Senior Vice President
Celularity Inc.
Carlos.ramirez@celularity.com