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United States Patent (19) 11 Patent Number: 5,030,200 Judy Et Al

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United States Patent (19) 11 Patent Number: 5,030,200 Judy Et Al United States Patent (19) 11 Patent Number: 5,030,200 Judy et al. (45) Date of Patent: "Jul. 9, 1991 54 METHOD FOR ERADICATING INFECTIOUS 4,708,715 11/1987 Troutner et al. ....................... 604/6 BIOLOGICAL CONTAMINANTS IN BODY 4,878,891 1 1/1989 Judy et al. .............................. 604/5 TISSUES Primary Examiner-Stephen C. Pellegrino (75) Inventors: Millard M. Judy; James L. Matthews; Assistant Examiner-Michael Rafa Joseph T. Newman; Franklin Attorney, Agent, or Firm-Johnson & Gibbs Sogandares-Bernal, all of Dallas, Tex. (57) ABSTRACT (73) Assignee: Baylor Research Foundation, Dallas, A method for externally eradicating infectious patho Tex. genic contaminants, such as enveloped viruses, bacteria, * Notice: The portion of the term of this patent trypanosomal and malarial parasites, present in body subsequent to Nov. 7, 2006 has been tissues, such as blood, blood components, semen, skin, disclaimed. and cornea, before the treated body tissues are intro 21) Appl. No.: 433,024 duced into, or transplanted onto, the body of a human or an animal. Such method includes the steps of: (1) 22) Filed: Nov. 6, 1989 admixing an effective, non-toxic amount of photoactive compound, which has a selectively for binding to the Related U.S. Application Data infectious pathogenic biological contaminants present (63) Continuation-in-part of Ser. No. 67,237, Jun. 25, 1987, therein, with the body tissues outside the body to pro Pat. No. 4,878,891. duce resulting body tissues; (2) maintaining the resulting 51 Int. Cl.............................................. A61M 37/00 body tissues in a suitable container in which there is no (52) U.S. Cl. ......................................... 604/5; 424/529 net mass transfer, and (3) irradiating the resulting body 58) Field of Search ........................................ 604/4-6; tissues in the container for an effective period of time 424/101, 529-531; 128/395 with an effective level of radiation such that the radia tion penetrates the resulting body tissues and eradicates (56) References Cited the photoactive-compound-bound contaminants pres U.S. PATENT DOCUMENTS ent in the resulting body tissues and produces a decon 4,613,322 9/1986. Edelson ............................... 354/321 taminated body tissue suitable for introducing into, or 4,614, 190 9/1986 Stanco et al. ....................... 28/395 transplanting onto, the body of a human or animal. 4,649,151 3/1987 Dougherty et al. ................ 514/410 4,684,521 8/1987 Edelson ............................... 424/10 66 Claims, 7 Drawing Sheets SYRINGE WITH BODY FLUID ATTACHED TO ATTACHED TO INFUSION PUMP COLLECTING WIAL U.S. Patent July 9, 1991 Sheet 1 of 7 5,030,200 SYRINGE WITH BODY FLUID ATTACHED TO ATTACHED TO INFUSION PUMP FIG. 7 COLLECTING WIAL FIG 2 PLANAR SUPPORT U.S. Patent July 9, 1991 Sheet 2 of 7 5,030,200 U.S. Patent July 9, 1991 Sheet 3 of 7 5,030,200 Y 22/ YZ W O * 30 i. /// FIG.REFLECTING 5 MIRROR Z REFLECTING MIRROR FIG. So U.S. Patent July 9, 1991 Sheet 4 of 7 5,030,200 Io Z44YY7 - - Y - YYZZY- - - - Y - 7 - 27-72-777-777 title -- assasaasayasses ease etes SA AC--------sea As Yasaw CWEleaayaays ZZZZZZZZZZZZYA. O. as 7 NYNNNNNNNNNNNNNNNN ILLUMINATED SURFACE OF THE IRRADIATION CELL FIG. Io U.S. Patent July 9, 1991 Sheet 5 of 7 5,030,200 AISNN HS) WW3 U.S. Patent July 9, 1991 Sheet 6 of 7 5,030,200 U.S. Patent July 9, 1991 Sheet 7 of 7 5,030,200 5,030,200 1 2 Localization of Pulmonary Malignancy, In Recent Re METHOD FOR ERADICATING INFECTIOUS sults in Cancer Research, Vol. 82, Springer-Verlag, Ber BIOLOGICAL CONTAMINANTS IN BODY lin-Heidelberg, 1982,90; Benson, R. D., et al, Detection TISSUES and Localization of In Situ Carcinoma of the Bladder with Hematoporphyrin Derivative. Mayo Clinic Proc., BACKGROUND OF THE INVENTION 57: 548, 1982). The present application is a continuation-in-part of Although the unique photodynamic properties of U.S. patent application Ser. No. 07/067,237 now U.S. Hpd, as well as its affinity toward tumor cells, had long Pat. No. 4,878,891, filed on Jun. 25, 1987, which is in been known, it was more than half a century later that corporated by reference as if reproduced in its entirety. O the potential of using Hpd to selectively destroy tumor 1. Field of the Invention cells was explored. The bulk of the research on the use The present invention relates generally to decontami of Hipd to selectively destroy tumor cells in human has nation of body tissues; and more particularly, but not by been reviewed by Dougherty et al. (Dougherty, T. J. et way of limitation, to external eradication of infectious al., Photoradiation Therapy-clinical and Drug Ad pathogenic biological contaminants from blood or 15 vances. In Porphyrin Photosensitization, D. Kessel and T. blood products prior to intravenous injection of such J. Dougherty, Eds., Plenum Press, N.Y. PP. 3-13, blood or blood products into a patient's body. 1983). The present invention also relates to external eradica The emphasis on using Hpd as the photoactivating or tion of infectious pathogenic biological contaminants light-activating compound in photoradiation of tumors from skin, cornea or semen prior to transplanting or 20 is based on two important properties of Hpd. Firstly, as introducing of such tissues into the recipient's body. judged by fluorescence, Hpd is preferentially accumu 2. Brief Description of the Prior Art lated, and retained to a higher degree in malignant tu One of the many problems that plagues the use of mors than in surrounding normal tissue or benign tu blood transfusions is the transmission of agents causing mors. Secondly, when properly photoactivated, Hpd infectious disease. A number of these infectious agents 25 causes the destruction of cells and tissue in which it are of serious clinical importance in that such agents are not only dangerous to the recipient patients, but can resides. The generally accepted mechanism of cell kill also pose a danger to physicians, and other hospital by Hpd is that when activated by appropriate light, the personnel, handling the blood and blood products. Hpd can undergo an energy transfer process with oxy Many efforts have been made to ensure that the blood 30 gen to form a singlet oxygen, which subsequently oxi to be transfused is free of pathogenic biological contam dizes, hence kills the cells or tissues to which it has inants. So far, screening of blood donors and blood attached as a substrate. (Weishaupt, K. R., Gomer, C.J. samples is the only effective method to ensure that the and Dougherty, T. J., Identification of Singlet Oxygen blood to be transfused is not contaminated with infec as the Cytotoxic Agent in Photoinactivation of a Mu tious agents. Unfortunately despite screening tech 35 rine Tumor. Cancer Res. 36: 2326-2329, 1976). niques, infections still occur following blood transfu Despite the enormous progress and research in the SOS use of light-activated photosensitizer, such as Hpd, to U.S. Pat. No. 3,041,242 describes a process for eradi pinpoint the location of malignant tumor cells and to cation of virus contained in dried plasma wherein the eradicate them, relatively little work has been done to dried plasma is heated at an elevated temperature for a 40 determine if such a photosensitizer will behave similarly length of time followed by applying a gas lethal to toward virus, bacteria, fungi, protozoa, or other para microorganisms, under high vacuum conditions. How sites. ever, the method is not applicable to the treatment of U.S. Pat. No. 4,649,151 to Dougherty, et al., discloses human whole blood; and the viability of the dried the preparation, purification and utilization of tumor plasma would most likely be impaired during the pro 45 selective, photosensitizing drugs (i.e. mixtures of por CSS. phyrins) in the localization and treatment of neoplastic It has been known for over 30 years that hematopor tissue, such as tumors or cancers in patients and animals. phyrin derivatives accumulate in neoplastic, embryonic, A time delay of several hours to several days is required and regenerating tissues. Thus, injected hematoporphy between injection of the drug and illumination in order rin has been found to have localized and fluoresced in 50 for the drug to metabolically clear normal tissue and several types of tumor induced in mice (Figge, F. H. J., hence achieve the best therapeutic ratio of drug in Weiland G. S., Mangiollo, L. O.: Cancer Detection and tumor cells to drug in normal cells. One of the objects Therapy. Affinity of Neoplastic, Embryonic, and Trau set forth in Dougherty, et al., is to provide a drug which matized Tissues for Porphyrins and Metalloporphyrins. is selective to certain pathogens within an animal or Proc. Soc. Exp. Biol. Med. 64: 640-641, 1948). 55 within blood, blood plasma or serum or fractions The red fluorescence of hematoporphyrin has also thereof and which permits photochemical destruction been observed under ultraviolet light in various malig of the pathogens in vivo or in vitro. However, the refer nant tumors in patients who had been given large doses ence contains no teaching or suggestion of the external of crude mixtures of hematoporphyrin compounds purification of human tissues such as human blood, (hereinafter referred to as Hpd) (Rasmussen-Taxdal, D. 60 blood plasma, serum, semen, skin or cornea utilizing a S., Ward, G. E., and Figge, F. H. J.: Fluorescence of mixture of porphyrins to eradicate infectious pathogens Human Lymphatic and Cancer Tissues Following High and to provide purified and sterilized human tissues Doses of Intravenous Hematoporphyrin. Cancer 8: . such as human blood, blood plasma, human serum, se 78-81, 1955).
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