Cell Therapy

About Cell Therapy

Lineage Cell Therapeutics is a leader in pluripotent cell product development and lineage derivation protocols. Pluripotent cells, which are widely published as capable of being induced to become any cell type of the human body, have many potential applications in medicine. Our objective is to develop new treatments for conditions with large unmet patient needs, including certain age-related degenerative diseases and other serious medical conditions for which there presently are no cures or few treatment options.

Unlike pharmaceuticals that require a molecular target, cellular therapies are often aimed at regenerating or replacing affected or absent cells and/or improving bodily functions such as immune surveillance. Therefore, cellular therapies may be shown to have broader or more suitable applicability than many pharmaceutical products available today. Small molecules and biologic therapies that require systemic delivery into the body often have unexpected results, or side effects, that can limit their usefulness. Cell replacement to the eye or spinal cord is locally administered, so systemic side effects are usually not a major concern. For systemic administration of cells, the risk profile more closely resembles that of transplant medicine, focused more on whether the transplanted cells are rejected by the body and whether the cells function as expected.

Lineage Cell Therapeutics is a leader in pluripotent cell product development and lineage derivation protocols. Pluripotent cells, which are widely published as capable of being induced to become any cell type of the human body, have many potential applications in medicine. Our objective is to develop new treatments for conditions with large unmet patient needs, including certain age-related degenerative diseases and other serious medical conditions for which there presently are no cures or few treatment options.

Unlike pharmaceuticals that require a molecular target, cellular therapies are often aimed at regenerating or replacing affected or absent cells and/or improving bodily functions such as immune surveillance. Therefore, cellular therapies may be shown to have broader or more suitable applicability than many pharmaceutical products available today. Small molecules and biologic therapies that require systemic delivery into the body often have unexpected results, or side effects, that can limit their usefulness. Cell replacement to the eye or spinal cord is locally administered, so systemic side effects are usually not a major concern. For systemic administration of cells, the risk profile more closely resembles that of transplant medicine, focused more on whether the transplanted cells are rejected by the body and whether the cells function as expected.

Lineage is developing three cell therapy programs (see our Pipeline):

  • OpRegen® – a cell replacement therapy comprised of retinal pigment epithelium cells and currently being tested in a Phase I/IIa multicenter clinical trial for the treatment of advanced dry age-related macular degeneration (dry AMD) with geographic atrophy. The development of OpRegen has been partially supported by more than $14 million of grants from the Israel Innovation Authority. OpRegen has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA).
  • OPC1 – a cell replacement therapy comprised of oligodendrocyte progenitor cells and currently being tested in a Phase I/IIa multicenter clinical trial for the treatment of acute spinal cord injuries (SCI). The development of OPC1 has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine or CIRM. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug Designation by the FDA.
  • VAC2 – an allogeneic (non-patient-specific or “off-the-shelf”) cancer immunotherapy comprised of mature, antigen-presenting dendritic cells and currently being tested in a Phase I clinical trial in patients with non-small cell lung cancer (NSCLC). VAC2 has been partially supported by Cancer Research UK, the world’s largest independent cancer research charity, and which is responsible for costs and conduct of the clinical trial.