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
- Acceptance of Celularity's abstract for a poster presentation at the 12th World Biomaterials Congress showcases the potential uses of Celularity biomaterials in regenerative medicine applications.
- The study focuses on utilizing tri-layer decellularized, dehydrated human amniotic membrane technology as a carrier for induced pluripotent stem cell derived-limbal stem cells for the treatment of limbal stem cell deficiency (LSCD).
- Celularity's research aims to address ocular surface disorders and degenerative diseases by developing advanced biomaterial products and allogeneic cell therapies.
- The collaboration with North Carolina State University's Gluck Tissue Engineering Laboratory emphasizes Celularity's commitment to advancing ocular regenerative medicine closer to clinical applications.
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Insights
The recent advancements presented by Celularity Inc. in the field of regenerative medicine, particularly their work on tri-layer decellularized, dehydrated human amniotic membrane (DDHAM) as a carrier for induced pluripotent stem cell-derived limbal stem cells (iPSC-LSC), represent a significant step in treating limbal stem cell deficiency (LSCD). The integration of biomaterials with stem cell technology is a burgeoning area of medical research, with the potential to revolutionize the treatment of degenerative diseases and tissue repair.
LSCD is a condition that can lead to blindness and the current treatment involves the transplantation of limbal stem cells. However, the use of DDHAM as a scaffold for iPSC-LSCs could offer a more accessible and potentially more effective treatment option. This is because iPSCs can be derived from the patient's own cells, reducing the risk of immune rejection and DDHAM provides a supportive environment for these cells to proliferate and restore the damaged ocular surface.
From a research perspective, the study's findings could open new avenues for the application of placental biomaterials in ocular regenerative medicine. The commercial availability of DDHAM could also improve patient access to treatment. However, it's essential to consider that the transition from laboratory research to clinical application involves rigorous testing and regulatory approval processes, which can be lengthy and expensive.
Delve Insight's data indicating the United States as having the highest number of diagnosed prevalent cases of LSCD suggests a significant market opportunity for Celularity's regenerative medicine technologies. The market for ocular diseases is substantial and growing, driven by an aging population and increased prevalence of conditions that can lead to LSCD, such as diabetes. Celularity's work in developing off-the-shelf DDHAM products combined with iPSC-LSCs could position the company as a leader in this niche market.
Investors should monitor the progression of Celularity's research and potential partnerships, like the collaboration with the Gluck Tissue Engineering Laboratory. Such collaborations could accelerate the product's path to market and enhance its credibility in the medical community. The impact on Celularity's stock could be substantial if the product demonstrates clinical efficacy and gains regulatory approval, as it would address an unmet medical need with a novel solution.
However, the biotechnology sector is highly volatile, with success dependent on clinical trial outcomes and regulatory milestones. Stakeholders should be aware of the risks associated with investing in companies like Celularity that are in the development stage of their product pipeline.
Celularity's announcement concerning the acceptance of their abstract for presentation at the World Biomaterials Congress could be seen as a positive indicator of the company's scientific credibility and the potential of its technology. Such events can raise the visibility of the company's research among potential investors and industry partners. However, the financial implications of this development are not immediate and hinge on the successful translation of research findings into approved treatments.
Financially, the key factors to watch in relation to Celularity's stock performance will be the costs associated with ongoing research and development, the timeline for clinical trials and the potential revenue from the commercialization of the technology. It's important to note that the biotech industry typically requires substantial capital investment before generating returns and Celularity's financial health will be a critical factor in its ability to sustain long-term research and development efforts.
Investors should also consider the competitive landscape, as other companies may be developing similar technologies. The ability to secure patents and exclusive licensing agreements will be crucial for Celularity to protect its intellectual property and market share.
-Highlights potential uses of Celularity biomaterials in regenerative medicine applications that combine stem cells and biomaterial scaffolds for use in constructing tissues and for cell delivery
-Poster Presentation at the 12th World Biomaterials Congress in Daegu, Republic of Korea
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 SVP, Investor Relations
Celularity Inc.
carlos.ramirez@celularity.com
FAQ
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