CellResearch Corporation - Source of cGMP Umbilical Cord Lining Stem Cells for COVID-19 Related Investigator Initiated Clinical Trials

SINGAPORE, June 10, 2020 /PRNewswire/ -- CellResearch Corporation (CellResearch), a regenerative medicine biotechnology company, is making its cGMP-grade umbilical cord lining stem cell product, CorLiCyte®, available complimentary to any licensed medical institution that is seeking to initiate clinical trials for the treatment of COVID-19 related therapies such as Acute Respiratory Distress Syndrome (ARDS). ARDS is a severe complication among many COVID-19 patients that results in lung parenchymal injury secondary to an inflammatory 'Cytokine Storm' generated by the infection.

Since being founded in 2002, CellResearch Corporation has built upon its discovery of the umbilical cord lining as a source of mesenchymal stem cells (MSCs). The company has developed its own patented technology and processes that have led to the production of three master cell lines of Current Good Manufacturing Process (cGMP) grade umbilical cord lining MSCs. The cGMP grade ensures that cell-based products are traceable, safe, pure and effective.

These cell lines are a biologic product under the name of CorLiCyte®. This biologic had its Investigational New Drug (IND) application accepted by the U.S. Food and Drug Administration (USFDA) in December 2018 for the treatment of chronic Diabetic Foot Ulcers (DFUs). CorLiCyte® is currently undergoing Phase 1 of a USFDA trial to close chronic DFUs at the University of Colorado Anschutz Medical Campus under the identifier NCT04104451.

Using technology developed by CellResearch Corporation, the master cell lines have been produced by ClinImmune Labs. ClinImmune Labs is an academic component within the Division of Allergy & Clinical Immunology, part of the Department of Medicine at the University of Colorado. ClinImmune is an FDA licensed, Biologics License Applications (BLA) laboratory, one of only 7 such institutions in the United States. ClinImmune Labs is accredited by the American Society for Histocompatibility and Immunogenetics (ASHI), the College of American Pathologists (CAP), the Clinical Laboratory Improvement Act (CLIA), the AABB (American Associations of Blood Banks), and the Foundation for Accreditation of Cellular Therapy (FACT).

Before establishing the fitness for release of CorLiCyte®, a rigorous and comprehensive suite of testing is performed. These tests include sterility assessment, HLA histocompatibility, and the detection of endotoxin, mycoplasma, adventitious infective agents and other human pathogens. A full breakdown of the tests conducted can be provided upon request. In addition to the testing of cell lines, the umbilical cord donor mothers are also fully screened to ensure the absence of transmittable diseases such as HIV and Hepatitis.

CorLiCyte® has properties that have the potential to treat and suppress ARDS that develops among a proportion of COVID-19 patients. These properties can aid in reducing the inflammatory 'Cytokine Storm' generated by the infection. The anti-inflammatory properties of the cells are particularly strong with high levels of production of anti-inflammatory cytokines such as Interleukin 10 (IL-10) and Transforming Growth Factor- Beta 1 (TGF- β1). Pro-regenerative cytokines such as Angiopoietin 1 (Ang 1) and Vascular Endothelial Growth Factor (VEGF) are also produced in substantial amounts. The proprietary media solutions used in Cord Lining Mesenchymal Stem Cell culture also ensure an extremely high purity approaching 99% as assessed by the presence and absence of specific Cluster Differentiation (CD) markers. The cells have been demonstrated to have particularly low immunogenicity, making them good candidates for allogeneic transplantation.

"Amid the COVID-19 pandemic, there is a growing awareness around the potential for regenerative medicine to treat inflammatory diseases such as ARDS. Given that we hold what we believe to be the highest quality line of umbilical cord lining stem cells with extremely high purity, we wanted to make sure that they are made available free of charge to the medical community," CellResearch CEO Gavin Tan said.

Professor Brian Freed, Director of ClinImmune Laboratories at Colorado University stated: "As the contracted cGMP production facility for CellResearch Corporation's 'CorLiCyte®' USFDA trial MSC product, we analyzed specific MSC markers and found that CorLiCyte® achieves 99% purity without manipulation, while bone marrow MSCs only achieved two-thirds of this level. This is an important advantage given bone marrow MSCs are widely considered to be the current gold standard of stem cell work."

Should any interested parties seek further information, please do reach out to us and our medical experts can help in answering any questions that you may have.

About CellResearch Corporation

CellResearch Corporation was founded in 2002 initially as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialise this technology in most of the major markets globally. While the closure of diabetic foot ulcers is the company's first allogeneic therapy to make it to Phase 1 USFDA clinical trials, CellResearch has a broad therapeutic pipeline at the pre-clinical stage. Further therapies include solid tumour therapy, inflammatory diseases, cardiac muscle repair, Parkinson's Disease, Age-related Macular Degeneration and Diabetes.

CellResearch partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife have what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

www.cellresearchcorp.com

About ClinImmune Labs

ClinImmune Labs is an academic enterprise of the University of Colorado Anschutz Medical Campus with an FDA-licensed, cGMP stem cell/cord blood bank. ClinImmune Labs is a highly efficient academic business that integrates the highest quality laboratory services and products with its scholarly mission to contribute to the science of stem cell therapy, histocompatibility and immunogenetics. ClinImmune Labs  is accredited by the American Society for Histocompatibility and Immunogenetics ("ASHI"), the College of American Pathologists ("CAP"), the Clinical Laboratory Improvement Act ("CLIA"), the American Associations of Blood Banks ("AABB"), and the Foundation for Accreditation of Cellular Therapy ("FACT").

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