Claims for Patent: 7,628,996

Summary for Patent: 7,628,996

Title:	Sterile immunogenic non-tumorigenic tumor cell compositions and methods
Abstract:	This invention relates to methods of removing bioburden from an aggregate of cells to obtain sterile cells that remain viable and immunogenic for the production of vaccines. This invention further relates to a method of eliciting an immune response to prevent a recurrence of metastases that involves preparing and administering a sterile vaccine derived from solid tumors. The vaccine is prepared by excising a solid tumor from a cancer patient, digesting the tumor cells with an enzyme to obtain dissociated cells, irradiating the dissociated cells to render the cells non-tumorigenic, and sterilizing the cells.
Inventor(s):	Haspel; Martin V. (Seneca, MD), Pomato; Nicholas (Frederick, MD), Hanna, Jr.; Michael G. (Frederick, MD)
Assignee:	Intracel Resources LLC (Frederick, MD)
Application Number:	10/370,081
Patent Claims:	1. A method for eliciting an immune response, comprising: excising solid tumor tissue from a cancer patient, processing the tumor tissue to reduce endogenous bioburden, digesting the tumor tissue with an enzyme to obtain viable dissociated tumor cells, irradiating said viable dissociated tumor cells at a dose of about 100,000 to 200,000 rads while frozen to render said viable tumor cells non-tumorigenic and sterile, and administering to said patient said viable sterile non-tumorigenic cells in a dose and a regimen sufficient to elicit an immune response. 2. The method of claim 1, wherein said irradiating is at a dose of at least 150,000 rads. 3. The method of claim 1, wherein said dose comprises about 10.sup.7 viable tumor cells and is comprised of a tumor cell population which is at least 80% viable. 4. The method of claim 3, wherein said treatment regimen begins 4-5 weeks after removal of the tumor and is comprised of at least three doses given at weekly intervals. 5. The meted of claim 4, wherein the first two of said three doses is combined with an adjuvant or immunostimulator. 6. The method of claim 4, wherein the patient is injected with a fourth dose five or more months after the first injection. 7. The method of claim 1, further comprising forceful washing of said tumor with a physiological solution prior to excision. 8. The meted of claim 7, further comprising washing said tumor with a detergent prior to excision. 9. The method of claim 8, wherein the detergent is selected from the group consisting of Triton X-100, NP40 and Tween 80. 10. The method of claim 1, further comprising the transport of said excised tumor in a physiological solution with antibiotics at a temperature of 0 to 6.degree. C. 11. The method of claim 1, further comprising treatment of the tumor, after excision, with a disinfectant solution at a concentration and for a duration that provides anti-microbial activity while minimizing cytotoxicity. 12. The method of claim 11, wherein the disinfectant is selected from the group consisting of sodium oxychlorosene, sodium hypochlorite and stabilized chlorine dioxide. 13. The method of claim 1, wherein the enzyme is collagenase. 14. The method of claim 1, wherein the digesting is performed in the presence of at least one of an antibiotic and anti-mycotic agent to reduce bioburden. 15. The method of claim 14, wherein the antibiotic is selected from the group consisting of imipenem and levofloxacin. 16. The method of claim 1, wherein the tumor cells are cryopreserved after digestion by controlled rate freezing at about -1.degree. C./minute to a temperature of about -80.degree. C. and maintained in a cryogenic state until thawed prior to administering to the patient. 17. The method of claim 1, wherein the irradiating is in an amount of 190,000 or more rads.

Details for Patent 7,628,996

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2022-02-22