Celularity and New York Medical College Partner on a Breakthrough Study to Treat RDEB with Human Placental Derived Stem Cells

WARREN, N.J., May 17, 2018 /PRNewswire/ -- Celularity, Inc. ("Celularity"), a biotechnology company that produces lifesaving cell therapies from the postpartum placenta, announces that it is sponsoring an investigative study on the use of its proprietary human placental derived stem cells (HPSC) to treat recessive dystrophic epidermolysis bullosa (RDEB). RDEB is an inherited genetic disorder in which severe lifelong skin blistering occurs because of a type VII collagen defect. RDEB causes blisters that cover nearly all skin surfaces and mucous membranes, often leaving large areas of the body devoid of skin. This leads to widespread scarring and deformity in which fingers and toes may become immobile and fuse together, and hands and arms may become fixed in a flexed position. Persons with severe RDEB are at enhanced risk of vision loss, and for developing squamous cell carcinoma.

The study is led by Mitchell Cairo, M.D., of the New York Medical College, where he is Chief of Pediatric Hematology, Oncology and Stem Cell Transplantation, and Professor of Pediatrics, Medicine, Pathology, Microbiology & Immunology and Cell Biology & Anatomy. During the course of this study, Celularity scientists will work with Dr. Cairo and his team to investigate HPSC's efficacy to relieve or significantly reduce the symptoms of this devastating disease, which affects tens of thousands of people in the United States and globally.

Human placental-derived stem cells (HPSC) is a novel Celularity stem cell product isolated via proprietary processes from full?term placentas. HPSC demonstrate phenotypic and functional differences from human umbilical cord blood (HUCB) even though both originate from placentas. HPSC are largely negative for major histocompatibility complex (MHC) class II molecules, with demonstrated safety and efficacy when used without human leukocyte antigen (HLA) matching as universal donor cells.

A recent animal model study published in the 10 May 2018 edition of the online journal Stem Cells Translational Medicine demonstrated HPSC's significant therapeutic benefits in a mouse model of RDEB without any conditioning regimen. HPSC effectively migrated to organs affected by RDEB, deposited the missing protein, and significantly improved the adherence of the epidermis to the dermis of the skin without inducing anti?C7 antibodies. Celularity's scientific team was led by Xiaokui Zhang, Ph.D., Chief Scientific Officer, and Jodi Gurney, Chief Innovation Officer.

"Dr. Cairo and his team demonstrated HPSC in combination with human cord blood can promote wound healing and ameliorate blistering in a RDEB mouse model," says Dr. Zhang. "The study demonstrated the therapeutic effects of HPSC are even greater than for HUCB alone," says Ms. Gurney, who adds, "HPSC contain significantly higher levels of hematopoietic and nonhematopoietic stem and progenitor cells than HUCB and are low in T cell content."

There is no cure today for RDEB. Available treatments aim to prevent blisters from forming and to manage symptoms when they do. There is an urgent need for an effective therapy to alleviate both the external and internal symptoms of RDEB and to prevent the disease's occurrence in the first place.

"We are excited and encouraged by these results, which hold out promise to RDEB patients who have a critical unmet medical need," states Robert J. Hariri, M.D., Ph.D., Celularity's Founder, Chair and CEO. "These data demonstrate once again HPSC's compelling regenerative potential, and their ability to augment the body's ability to repair itself and restore normal functionality. Celularity is actively exploring other ways to use our powerful cell therapy tools to benefit patients."

Celularity's Chief Medical Office, Jerome Zeldis, M.D., Ph.D., commented on the opportunity to apply HPSC's therapeutic benefits to other autoimmune diseases, such as graft-versus-host disease (GvHD). "Both acute and chronic GvHD are major causes of disability and death when patients receive unrelated bone marrow transplantation for serious medical conditions," says Dr. Zeldis. "The interim analysis of this multi-center trial is suggestive that HPSC added to unrelated stem cells reduce GvHD and its complications."

Celularity is leveraging its proprietary placental-derived cell therapy platform in targeted disease indications. Celularity recently initiated in partnership with Sorrento Therapeutics, an Anti-CD38 CAR-T Phase 1 Clinical Trial in patients with relapsed or refractory multiple myeloma. The companies' CD38 CAR-T program is their most advanced program targeting this difficult-to-treat condition. ?It is currently the only active US-based clinical trial targeting CD38 using a CAR-T cell therapy.

Visit www.celularity.com to learn more about Celularity.

About Celularity:                  
Celularity (www.celularity.com) is a biotechnology company that harnesses the power of placenta-derived cells and tissue to create transformative therapeutic options for complex medical conditions. Celularity's intellectual property and research portfolio consists of 800 issued patents as well as pre-clinical and clinical assets, including CAR constructs for allogeneic CAR-T/CAR-PNK products, licenses to 100+ immunotherapy assets, and commercial-stage biosourcing and functional regeneration businesses.

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SOURCE Celularity, Inc.