Universal donor cells are next-generation induced pluripotent stem cells (iPSCs) that have been created using gene-editing technology to engineer a low risk of immune rejection regardless of human leukocyte antigen (HLA) type.

HLA types help the body recognize foreign substances. Typically, transplanted cells trigger an immune rejection response in patients whose HLA type does not match that of the cells. Therefore, immunosuppressant drugs are usually administered. Using iPSCs, cells produced by the patient's own cells are preferred, but the process is time consuming and expensive.

Therefore, universal donor cells lower the risk of immune rejection while preserving the inherent ability of iPSCs to replicate and differentiate into various cell types. Healios' universal donor cells technology involves three steps:

• The removal of certain HLA genes that elicit a rejection response
• The introduction of an immunosuppression gene to improve immune evasion
• The addition of a suicide gene serving as a safety mechanism, each in an allogeneic iPSCs

Healios plans to combine the universal donor cell technology with cancer-targeting immune cells, ophthalmology, and organ buds regenerative medicine therapies. The company is working toward the early completion of a clinical-grade universal donor cell line that meets global approvability standards.

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