This document addresses adoptive immunotherapy and cellular therapy. Adoptive immunotherapy is a general term describing the transfer of immunocompetent cells (for example, lymphocytes) to the tumor-bearing host. The major research challenge in adoptive immunotherapy is to develop immune cells with specific anti-tumor reactivity that could be generated in large enough quantities for transfer to the tumor-bearing host.

Cellular therapy (also known as fresh cell treatment) involves the injection or ingestion of tissue (for example, cartilage, embryonic, organs, fetal, glandular) obtained from animal (for example, sheep, cow and shark) tissues. It has been proposed as a treatment of acquired immune deficiency syndrome, arthritis, asthma, chronic fatigue, cancer, diabetes, hypertension, colonic diverticulum as well as other conditions or diseases.

Note:

• Donor lymphocyte infusion, used to treat recurrences in individuals who have undergone an allogeneic transplant, is a form of adoptive immunotherapy and is addressed in CG-TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies after Allogeneic Hematopoietic Progenitor Cell Transplantation.
• There are United States Food and Drug Administration (FDA) approved and pharmacopeia recognized off-label uses of interleukin-2 (IL-2) which are not related to adoptive immunotherapy and not addressed by this document.

Position Statement

Investigational and Not Medically Necessary:

Adoptive immunotherapy is considered investigational and not medically necessary in all cases.

Types of adoptive immunotherapy include but are not limited to:

• Adoptive immunotherapy using tumor-infiltrating lymphocytes, lymphokine-activated killer cells, activated in vitro by recombinant or natural interleukin-2 or other lymphokines, or antigen-loaded dendritic cells, or cytokine-induced killer cells.
• Autolymphocyte therapy, using peripheral T-cells stimulated in vitro by OKT3 monoclonal antibody in conjunction with interleukin-2.

Cellular therapy (also known as fresh cell treatment) is considered investigational and not medically necessary in all cases.