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The Issels Vaccine Program

Extensive experience with the integration of cancer vaccines into a comprehensive personalized treatment program has achieved a unique track record of unusual results. This approach distinguishes itself decisively from the mere administration of vaccines.

Vaccines

•  Extracorporeal photopheresis with the autologous dendritic cell vaccine, FDA-approved for cutaneous T-cell lymphoma due to research by Richard L. Edelson, Carole L. Berger et al.

Via the photopheresis device, pathogens and abnormal cells are destroyed through exposure to ultraviolet light, which also has an enormous immune-boosting effect. During this procedure, monocytes are separated from the blood then cultured to maturity; converting them to active dendritic cells. These are injected into the patient in small customized doses over a certain period of time.

•  Coley's mixed bacterial vaccine

Research findings suggest that this vaccine activates the innate immune system, opens blockades in the body’s connective tissues, enhances the formation of the body’s own interferons, interleukins, colony stimulating factors, tumor necrosis factor, and other potent disease fighters.

•  Issels’ Autologous vaccine

Issels autologous vaccine is cultured from the patient’s own blood that represents his/her own unique internal bodily environment. The preparation follows procedures that favor the development of antigenic peptides and other immunogenic compounds aiming to enhance the body’s cancer fighting mechanisms.

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"Immunotherapy may be one of the only ways left to deal with cancer. We’ve gone as far as we can with chemotherapy," says oncologist Herman Kattlove, an editor for the American Cancer Society. With few new drugs coming out, he says, "chemotherapy is sort of a dead area..." With dendritic cells, "what convinced me is that we saw responses," says Dr. Levy (Stanford University). -- New Weapon in Cancer War. The Wall Street Journal, May 23, 2003: B1.

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DISCLAIMER: The extent of the response to the vaccines or the overall treatment varies from patient to patient, even with similar diagnosis. Even if the type of the cancer cells is the same, the internal bodily environment on which these cells grow, is unique to each individual patient.

>>> For ADDITIONAL INFORMATION on Treatment and Costs please click here or call 1.888.447.7357

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Background

Extracoporeal photopheresis with the autologous dendritic cell vaccine

Dendritic cells (DC) are highly specialized antigen-presenting cells and play a key role in the immunological reactions throughout the body. They are responsible for identifying pathogens such as viruses, fungi, bacteria, and malignant cells, by presenting their identifying markers (antigens) to specific T lymphocytes, which then multiply and attack only the diseased cells, not normal healthy cells.

Since the first clinical trial (Nestle FO, et al. “Vaccination of melanoma patients with peptide- or tumor lysate-pulsed dendritic cells.” Nat. Med. 4 Mar 1998; 4(3):269-70) was published in 1998, the number of clinical trials with dendritic cell vaccines for various types of cancer has been increasing rapidly worldwide.

Our method of dendritic cell production and administration follows the model pioneered by Richard L. Edelson and Carole L. Berger of Yale University. This painless procedure is also called transimmunization and FDA approved for cutaneous T-cell lymphoma. During the past 5 years we have integrated it into our comprehensive immunobiological treatment program for all types of lymphomas and solid tumors. Experience has shown that a comprehensive immunobiological treatment which brings about connective tissue inflammation with its cytokine cascade, can enhance activation, mobilization, and maturation of dendritic cells, and herewith the effectiveness of the vaccines.

We administer the extracorporeal photopheresis and dendritic cell vaccine according to the individual patient’s type and stage of the cancer. Dosis and interval depend on the patient’s response and general condition. The side effects that some patients experience comprise a rise of body temperature for several hours and pain or tenderness in the tumor area for several days.

References:

Transfus Apheresis Sci. 2002 Jun;26(3):205-16. [Link to Article]

Transimmunization, a novel approach for tumor immunotherapy.

Berger CL, Hanlon D, Kanada D, Girardi M, Edelson RL.

Department of Dermatology, Yale University, School of Medicine, New Haven, CT 06510-8059, USA. carole.berger@yale.edu

This review describes our experience with the development of a novel form of immunotherapy that may represent the first practical and effective means of performing tumor-loaded dendritic cell (DC) immunotherapy. We have modified the highly successful extracorporeal photopheresis (ECP) treatment that has been used in the therapy of cutaneous T cell lymphoma (CTCL). autoimmune disease, transplantation rejection episodes and graft-versus-host disease to enhance its efficacy by the addition of an overnight incubation period. This adaption of ECP is termed "transimmunization (TI)" since the new therapy permits transfer of tumor antigens that have been previously poorly recognized to potent antigen presenting cells where the tumor epitopes can be displayed in the full context of major histocompatibility, co-stimulatory and adhesion molecules. The TI modification of ECP is a practical and safe means of rapidly inducing DC differentiation from peripheral blood monocytes in the presence of apoptotic tumor cells. Uptake of the apoptotic CTCL cells by the immature DC, in the presence of inflammatory cytokines, further drives their maturation into potent antigen presenting cells. Reinfusion of these tumor-loaded DC, that have access to the full spectrum of tumor antigens, has the potential to invoke an anti-tumor immune response in the recipient. Standard ECP has been a very useful form of immunotherapy and a modification of this approach that can enhance its ellicacy and utility should broaden its application to a larger variety of disorders including potentially the treatment of solid tumors and the modulation of the immune response in graft-versus-leukemia and graft-versus-host transplantation regimens. An understanding of the mechanism of ECP and TI will provide the physician with the ability to more finely tune the desired immune response and thereby, provide an enhanced immunotherapy for malignancy and other disorders of immunocompetence.

Mixed Bacterial Vaccine or Coley’s Toxins

Fever inducing Mixed Bacterial Vaccine treatment has been an integral part of the comprehensive Issels Treatment since 1951.

This treatment of cancer was pioneered by William B. Coley, who was the Attending Bone Surgeon at Memorial Hospital, now Memorial Sloan Kettering Cancer Center New York, from 1893 to 1936.

Mixed Bacterial Vaccines (MBV) contain a combination of heat killed bacteria, e.g. gram positive Streptococcus pyogenes and gram negative Bacillus prodigiosus, now called Serratia marcescens. In 1943, M.J. Shears, researcher at the National Cancer Institute, discovered that the biologically active substance in Coley's Toxins is lipopolysaccharide (LPS) that occurs in the cell walls of gram-negative bacteria.

Administered intramuscularly or intravenously, depending on individual conditions of patients who qualify for this treatment, these vaccines induce fever for several hours. During the rise of the fever, patients get chills and feel flu-like symptoms, such as headache, back pain, nausea and pain in the tumor area. In some cases a drop of blood pressure has been observed. Tumors may swell during the fever treatment and sometimes, a few days thereafter, patients may notice a reduction in tumor size.

Research studies explain the anti tumor effect of Coley's Toxins through induction of interferon, augmentation of natural killer cell activity, stimulation of lymphoid tissues, activation of macrophages, induction of serum factor that causes necrosis of tumors, as well as stimulation of interleukin 2.

Fever therapy has not only a significant effect on the immune system but on all the defense zones, and especially the reticulo-histiocytary defense zone, the pluripotent mesenchyme (connective tissues). This is also referred to as the "regulatory ground system" which is the system of basic regulation.

Clinical research suggests that the restoration of the non-specific regulatory mechanisms of the ground system appears to be an important precondition for specific immunotherapy to reach its optimal effect.

Starting in 1951, in his hospital in Germany, Josef M. Issels, M.D. administered, as one part of his comprehensive immunotherapy, several 100,000 fever treatments without any adverse side effects or complications to thousands of his patients suffering from progressive metastatic cancer. He was the only physician systematically applying this treatment to a large patient population. Studies carried out in his hospital comparing the white blood count before and shortly after fever therapy showed the remarkable immune enhancing effect of fever therapy.

References:

Issels Autologous Vaccine

Clinical research suggests that the vaccine works in a very complex way on the levels of cell-mediated and humoral immunity, and stimulates the formation and activation of T-helper cells. It is cultured from the patient’s own blood that represents his/her own unique internal bodily environment. The preparation follows procedures that favor the development of antigenic peptides and other immunogenic compounds aiming to enhance the body’s immune functions.

The vaccine is sterile. Since it is custom prepared from the patient's own blood, many side effects typically associated with other treatments are not experienced. A slight rise in temperature, fatigue, and tenderness in the tumor area are possible for a period of 6 - 48 hours after administration.

Experience has shown that the effectiveness of the vaccine, of any vaccine, is enhanced when it is administered within a comprehensive biological treatment program.

Dr. Josef Issels pursued research on immunological and microbiological aspects of cancer etiology since 1948. He established several research departments in his hospital from its inception in 1951. Already in the early years, Dr. Issels and his co-researchers developed cancer vaccines in the laboratories on the premises.

In 1970, the hospital grew from 85 to 120 patient beds and expanded its extensive research facilities such as the microbiological, immunological and dental departments, the hyperthermia department, etc.

From 1958 until 1973, Dr. Franz Gerlach was Director of Research of the microbiological department of Dr. Issels' hospital. Dr. Gerlach, was a professor of the University of Vienna, Austria, and represented Austria at the 1946 International Conference of Microbiology of Cancer. He worked at the Pasteur Institute in Paris, was a Fellow of the reputable Academy of Medicine in Paris, among other institutions, and was well known to cancerologists all over the world for his research on mycoplasmas and cancer. Dr. Issels' hospital became the only such institution of the era to conduct research on mycoplasmas in cancer and chronic degenerative diseases.

A variety of studies in Dr. Issels' microbiological department confirmed that mycoplasma species can be causative or co-factors in the development of cancer. For example, after cell free depot inoculation of mycoplasmas under the skin of 209 albino mice, 90.9% developed all types of malignancies, whereas of 600 control animals which were not inoculated, only 0.83% developed cancer.

Recent research by reputable scientists such as Drs. S.C. Lo, Chief of Molecular Pathology at the Armed Forces Institute of Pathology in Washington, D.C., S. Tsai, D.J. Wear, J.W. Shih, B. Zhang, R. Dudler, C. Schmidhauser and others, suggests an association between mycoplasmas and malignancy, as well as AIDS.

Drs. M. Nasralla, J. Haier, G.L. Nicolson, professor at M.D. Anderson Cancer Center, Houston, Texas, and the Institute for Molecular Medicine, Huntington Beach, California, et al. confirm the involvement of certain mycoplasma species in the Gulf War Syndrome, Chronic Fatigue Syndrome, Fibromyalgia, and Rheumatoid Arthritis.

For more than a century, international researchers have precisely documented certain microorganisms in human blood, body fluids and tissues, which were highly "pleomorphic", i.e. they can appear in various developmental stages and in diverse forms while maintaining their essential characteristics. When the host terrain deteriorates, they have been observed to transform from primitive structures into higher cyclogenetic structures. They can become pathogenic and may be causative or contributory factors in the development of malignancies, various chronic degenerative diseases and immune disorders. Some researchers have observed that disease causing higher cyclogenetic structures can be reversed by the administration of lower cyclogenetic structures.

Different scientists have given different names to these microorganism. However, they all have documented essential features in common: The microbes are stainable, cell wall deficient, virus-like and pleomorphic. They are classified as stealth pathogens.

References:

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>>> For ADDITIONAL INFORMATION on Treatment and Costs please click here or call 1.888.447.7357

DISCLAIMER: The extent of the response to treatment varies from patient to patient, even with similar diagnosis as the internal bodily environment is unique to each individual patient.

>> Back to top