Sterile immunogenic non-tumorigenic tumor cell compositions and methods

A method for preparing a sterile non-tumorigenic composition of viable tumor cells, comprising:

• obtaining tumor tissue;
• treating the tumor tissue with a disinfectant to reduce microbial contamination of the tissue;
• digesting the tissue with an enzyme to obtain dissociated tumor cells;
• freezing the dissociated tumor cells;
• applying a dose of irradiation to the frozen cells in an amount sufficient to inactivate microorganisms and tumorigenicity and preserve the viability of the cells to obtain sterile non-tumorigenic tumor cells;
• and
• wherein the sterile non-tumorigenic tumor cells have at least 80% viability as measured by Trypan Blue exclusion.

A method for preparing an injectable immunogenic dose of sterile non-tumorigenic colon tumor cells, comprising:

• washing colon tumor tissue with a wash solution containing a detergent;
• excising the washed tumor tissue from a colon cancer patient;
• treating the excised tumor tissue with a disinfectant to reduce microbial contamination of the tissue;
• digesting the tumor tissue with a dissociation enzyme, in the presence of at least one antibiotic and an anti-mycotic, to obtain at least about 107 dissociated tumor cells;
• freezing the dissociated tumor cells;
• applying a dose of about 150,000-200,000 rads of gamma radiation to the frozen tumor cells to render the tumor cells sterile and non-tumorigenic;
• combining the tumor cells with a pharmaceutically acceptable carrier for intradermal injection to prepare an injectable dose containing at least about 107 dissociated tumor cells;
• and
• wherein the dose contains sterile non-tumorigenic tumor cells having at least 80% viability as measured by Trypan Blue exclusion and elicits an immunogenic response when injected into a patient.