IL303111A - System and methods for treating cancer cells with alternating polarity magnetic fields - Google Patents

System and methods for treating cancer cells with alternating polarity magnetic fields

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Publication number
IL303111A
IL303111A IL303111A IL30311123A IL303111A IL 303111 A IL303111 A IL 303111A IL 303111 A IL303111 A IL 303111A IL 30311123 A IL30311123 A IL 30311123A IL 303111 A IL303111 A IL 303111A
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Israel
Prior art keywords
cancer cells
magnetic field
body area
target body
tme
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IL303111A
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Hebrew (he)
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Vivek K Sharma
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Vivek K Sharma
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Publication date
Priority claimed from US17/308,019 external-priority patent/US11344739B2/en
Priority claimed from US17/396,608 external-priority patent/US11344740B2/en
Application filed by Vivek K Sharma filed Critical Vivek K Sharma
Publication of IL303111A publication Critical patent/IL303111A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00Magnetotherapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00Magnetotherapy
    • A61N2/004Magnetotherapy specially adapted for a specific therapy

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Magnetic Treatment Devices (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Description

SYSTEM AND METHODS FOR TREATING CANCER CELLS WITH ALTERNATING POLARITY MAGNETIC FIELDS TECHNICAL FIELD [0001] The present invention involves treating rapidly proliferating or dividing cells, such as cancer cells, and more specifically to systems and methods for selectively inhibiting or destroying rapidly dividing cells by applying an alternating magnetic field having defined characteristics to a target area of a patient’s body. Some embodiments of the invention provide a wearable system capable of providing an ambulatory therapy to a non-stationary patient by applying a magnetic field to inhibit or destroy rapidly dividing cells to the target body area. BACKGROUND OF THE INVENTION [0002] Cell division is a reproductive process in all living systems, including without limitation simple one-celled organisms such as bacteria and protozoa, as well as more complex organisms such as algae, plants, and animals, including humans. The cell division cycle involves a series of events within the cell that leads to a duplication of the DNA of the cell, with one of the duplicate DNA sequences going to each of two daughter cells. Prokaryotic cells are one-celled organisms that lack an enclosed nucleus and reproduce by a cell division process known as fission. More complex organisms with enclosed nuclei are called eukaryotes, whose cells asexually reproduce by a three-part cell division process involving periods known as interphase, mitosis, and cytokinesis. In the reproduction of sexual cells (i.e., egg and sperm) of more complex organisms, mitosis is replaced by meiosis. [0003] During interphase, the parent cell produces nutrients and other components necessary for mitosis, and the DNA is duplicated as loosely packed chromatin. Mitosis involves separation of the duplicated DNA in the nucleus of the eukaryotic cell into two nuclei, each having a complete copy of the duplicated DNA. In cytokinesis, the cytoplasm, organelles & cell membrane are divided, forming two daughter cells of roughly equal size. [0004] The process of mitosis is further divided into the stages of prophase, prometaphase, metaphase, anaphase, and telophase. In prophase, the DNA duplicated during interphase condenses into discrete long, thin chromosomes having two chromatids joined by a centromere. Each cell has two centrioles, which move to opposite poles of the cell during prophase. Microtubules radiate from near the two centrioles toward the center of the cell, including some which extend to the chromatids and help to separate the two chromatids into separate daughter chromatids. In metaphase, the chromosomes move toward the cell equator and align in the metaphase plane (or equatorial plane). The daughter chromatids separate from each other at the equator during early anaphase by moving along the microtubule spindle fibers toward the centromeres at opposite poles of the cell, a process which elongates the cell. In late anaphase the daughter chromosomes each reach their opposite poles of the cell, and the cell membrane begins to pinch to form the two daughter cells, which is part of cytokinesis, or the process by which the daughter cells are separated. During telophase, the microtubules continue to lengthen and a new nuclear envelope forms around each of the separated daughter chromosomes, each of which has an identical set of chromosomes, and cytokinesis proceeds with further pinching of the two daughter cells toward becoming separate entities. By the end of telophase, the microtubule spindles disappear. Finally, the daughter cells fully separate, completing cytokinesis. [0005] Cancer cells and some non-cancerous cells (e.g., non-malignant tumors) proliferate or grow in an uncontrolled manner in contrast to normal cells. In addition to the extra space such tumors or cells occupy, they may also damage nearby normal cells. Cancer cells may also metastasize, traveling to other locations in the body, where they continue to hyperproliferate and may form new tumors. The rapid growth of tumors and cancer cells results from their rapid rate of cell division compared to normal cells. [0006] Many effective anti-cancer and anti-tumor therapies are based on the fact that cells in the process of dividing are more sensitive to radiation and many drugs than non-dividing cells. Because tumor cells divide much more frequently than normal cells, it is possible, by using therapies that act on tumor cells while they are dividing, to selectively damage or destroy them while leaving normal cells—which divide less frequently—less affected. However, because many types of cancer cells are only slightly more susceptible to radiation and/or chemotherapy agents than normal cells, it is not always possible to selectively affect tumor cells while leaving normal cells unaffected. Consequently, many radiation and chemotherapy agents significantly damage normal cells as well as tumor cells, leading to a significant patient burden (e.g., pain, scarring, organ damage, blood damage, impaired immune system function, etc.) for even "successful" treatments. [0007] In addition to radiation and chemotherapeutic agents, other therapies involving different modes of action have been used to treat tumor cells, including without limitation ultrasonic and electrical therapies. Electrical currents and electrical fields have been used for decades for medical purposes. [0008] One type of electrical therapy involves applying an electrical current through body tissue separated by two or more conductive electrodes. This type of therapy may be used, for example to stimulate or excite muscle or nerve tissue (e.g., pacemakers, defibrillators, neurostimulators) or to generate heat within a desired body tissue (e.g., thermal therapies to remodel collagen or to ablate tissue). Electrical therapies involving conductive electrodes may involve direct current or alternating current at a wide range of frequencies (e.g., less than 1 Hz to above 1 MHz). The energy from electrical currents is delivered to tissue based on the electrical conductive characteristics (e.g., resistance, capacitance) of the tissue. Since these properties are similar for both tumor and normal cells, such therapies affect both tumor and normal cells (e.g., destroying both by heat if they are within the current path) in the same manner. At lower frequencies (typically below 20 kHz), the use of conductive electrodes may be used to stimulate muscle or nerve tissue to activate muscle or nerve fibers. At frequencies used in many electrical therapies (e.g., tens of kHz to MHz), stimulation with conductive electrodes is too rapid for stimulation signals to propagate through such tissue and the signals are "shorted." [0009] Another medical use of electrical energy involves the use of insulated electrodes to deliver high frequency electrical energy radiatively or inductively to target tissue. For example, radio frequency (RF) or microwave energy may be applied radiatively to tissue through the air or another electrically insulating material separating the electrodes from the tissue being treated. The effect of this type of electrical energy on living tissue is based on the dielectric properties of the tissue rather than their conductive characteristics. [0010] More recently, insulated electrodes have been used to treat cancer cells and other rapidly proliferating cells by applying AC electric fields at frequencies of 50-500 kHz and electric field strengths of about 10 - 1000 V/m to a target body area that includes such cells. Such therapy is often referred to as TC ("tumor curing") field or TTF ("tumor treatment field") therapy. In US 6,868,289, which is hereby incorporated by reference in its entirety, a method and apparatus are disclosed for destroying rapidly proliferating cells using insulated electrodes to generate an electric field. At electric field frequencies of 50-500 kHz, the cell membranes of the dividing cells act to concentrate the electric field lines at the cleavage furrow separating the two daughter cells of the dividing cell. The high-density field at the cleavage furrow causes polarized or charged intracellular components within the cell to move toward the high-density field lines at the cleavage furrow, eventually disrupting the cell membrane at the cleavage furrow, and destroying the diving daughter cells. [0011] In US 8,019,414, which is hereby incorporated by reference in its entirety, a method of killing or destroying cancer cells is disclosed that involves applying an electric field together with another cancer therapy such as radiation or chemotherapy drugs. The electrical field may be a field such as that disclosed in the ‘289 patent. [0012] The use of electric fields to destroy cancer cells, while effective at certain frequencies and electrical field strengths, is limited in many practical respects. To provide a safe and consistent electrical field strength, the electrodes of systems such as those disclosed in the ‘298 and ‘414 patents must be in intimate contact with the tissue (e.g., skin) of the patient at all times during the treatment. To ensure good contact with the patient’s skin, it may be necessary to shave all hair from the skin to which the electrodes are coupled. Because the therapy may be delivered for an extended period of time, the electrodes frequently cause skin irritation at the electrode contact site. For example, in one recent study of TTF therapy, forty-three percent (43%) of patients experienced some skin irritation, with 1% reporting severe skin irritation. The relatively high incidence of skin irritation or pain may prohibit the therapy in sensitive body areas (e.g., breast tissue, etc.). TTF therapy also involves the use of relatively high voltages. For this reason, patients must be careful in performing everyday activities having a risk of water exposure (e.g., showering, exercise (sweating), or even exposure to rain). [0013] The use of electrodes in direct contact with the patient’s skin presents a risk of burning or heating of tissue adjacent to the electrodes. Because of this risk (and buildup of dirt, oils, etc.), the electrodes in TTF therapy systems typically require frequent replacement (e.g., twice each week). Patients wearing TTF electrodes on the scalp reported headaches related to wearing the electrodes 24 hours a day. [0014] TTF electrodes must also be placed by trained users (e.g., technicians or physicians). Because the treatment is highly localized (i.e., between the electrodes), precise location of the cancer/tumor must first be performed, and the electrodes must be placed with a high degree of accuracy to create an electric field that passes through it. If the electrodes are slightly off of optimal placement, the treatment may result in suboptimal results. [0015] In addition, although the ‘289 patent discloses ambulatory embodiments (i.e., embodiments in which the patent can wear and use the system in performing at least some ordinary non-stationary life activities such as walking, driving, shopping, etc.), in practice the power requirements (e.g., high voltages) for generating appropriate electric fields (e.g., at least 10 V/m) result in bulky and/or heavy electronics boxes that must be coupled to the electrodes and thus carried by the patient. One clinical study showed a relatively high rate of falls in patients carrying these cumbersome TTF electronics boxes. [0016] In view of these limitations to TTF systems, there is a need for safer therapies that may be applied for longer durations to destroy cancer or other rapidly-dividing cells. The many problems associated with electrodes also raise a need for new therapies that avoid a risk of skin pain or the need for continuous contact with skin or other tissue. Because the efficacy of the system depends upon how long the electric fields can be applied to the rapidly-dividing cancer cells, less bulky, heavy, and cumbersome systems are needed to permit truly ambulatory, long duration treatments. Finally, there is a need for therapy systems that do not require trained patients or clinicians for setup.
SUMMARY [0017] In one aspect, the present invention provides a system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator and to a target body area, wherein the one or more electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller for controlling one or more of the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.05-5 mT, wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, eliciting an immune response to the cancer cells, increasing tumor immunogenicity, decreasing immunosuppressive activity of the cancer cells, recruiting one of antigen-presenting cells and immune effector cells to the tumor microenvironment, or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed. [0018] In another aspect, the present invention provides a system for treating cancer cells in a target area of a patient’s body comprising: at least one electromagnetic coil coupled to a target body area; and a controller for controlling the at least one electromagnetic coil to generate and apply to the target body area an alternating polarity (AP) magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.05 - 5 mT, wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, eliciting an immune response to the cancer cells, increasing tumor immunogenicity, decreasing immunosuppressive activity of the cancer cells, recruiting one of antigen-presenting cells and immune effector cells to the tumor microenvironment (TME), or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed. [0019] In another aspect, the present invention provides a system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator and to a target body area, wherein the one or more electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; a controller for controlling the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.1-5 mT, wherein the AP magnetic field modifies the cancer microenvironment (TME) by at least one of: increasing the number of CD8+ lymphocytes in the TME; increasing the ratio of CD8+ to total lymphocytes in the TME; increasing the number of CD4+ lymphocytes; increasing the ratio of CD4+ to total lymphocytes in the TME; increasing the number of tumor infiltrating lymphocytes (TILs) in the TME; increasing the number of antigen presenting cells (APCs) in the TME; increasing the concentration of tumor-suppressive cytokines in the TME; decreasing the concentration of tumor-promoting cytokines in the TME; increasing the number of Mmacrophages in the TME; decreasing the number of M2 macrophages in the TME; decreasing one of the number or concentration of myloid-derived suppressor cells (MDSCs) in the TME; and increasing one of the number or concentration of natural killer (NK) cells in the TME. [0020] In another aspect, the present invention provides a system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; at least one electromagnetic coil coupled to the AP magnetic field generator and to a target body area, wherein the at least one electromagnetic coil is energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller for controlling the at least one electromagnetic coil and power supply to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.1-5 mT, wherein the AP magnetic field modifies the cancer microenvironment (TME) by at least one of: modulating the blood vessels surrounding the cancer cells; modulating the presence of fibroblasts proximate to the cancer cells; modulating immune cell signaling molecules proximate to the cancer cells; modulating the extracellular matrix surrounding the cancer cells; modulating resident host cells; modulating infiltrating host cells; modulating secreted factors proximate to the cancer cells; modulating the proteins surrounding the cancer cells; modulating the presence of pericycles proximate to the cancer cells; and modulating the presence of adipocytes proximate to the cancer cells. [0021] In one aspect, the present invention provides a method of treating cancer cells in a target body area of a patient, comprising: providing a magnetic field therapy system comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator, wherein the one or more AP electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller to control at least one of the first frequency and the first field strength of the AP magnetic field generated by the one or more AP electromagnetic coils; coupling the one or more AP electromagnetic coils to the target body area; generating an AP magnetic field having a first frequency of 0.1-500 kHz and a field strength of 0.2-5 mT using the one or more AP electromagnetic coils; applying the generated AP magnetic field to the target body area using the one or more AP electromagnetic coils, wherein the AP magnetic field modifies the tumor microenvironment to achieve at least one of: increasing the number of CD8+ lymphocytes in the TME; increasing the ratio of CD8+ to total lymphocytes in the TME; increasing the number of CD4+ lymphocytes; increasing the ratio of CD4+ to total lymphocytes in the TME; increasing the number of tumor infiltrating lymphocytes (TILs) in the TME; increasing the number of antigen presenting cells (APCs) in the TME; increasing the concentration of tumor-suppressive cytokines in the TME; decreasing the concentration of tumor-promoting cytokines in the TME; increasing the number of M1 macrophages in the TME; decreasing the number of M2 macrophages in the TME; decreasing one of the number or concentration of myeloid-derived suppressor cells (MDSCs) in the TME; and increasing one of the number or concentration of natural killer (NK) cells in the TME. [0022] In another aspect, the present invention comprises a method of treating cancer cells in a target body area of a patient, comprising: providing a magnetic field therapy system comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator, wherein the one or more AP electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller to control at least one of the first frequency and the first field strength of the AP magnetic field generated by the one or more AP electromagnetic coils; coupling the one or more AP electromagnetic coils to the target body area; generating an AP magnetic field having a first frequency of 0.1-500 kHz and a field strength of 0.2-5 mT using the one or more AP electromagnetic coils; applying the generated AP magnetic field to the target body area using the one or more AP electromagnetic coils, wherein the AP magnetic field modifies the tumor microenvironment to achieve at least one of: modulating the blood vessels surrounding the cancer cells; modulating the presence of fibroblasts proximate to the cancer cells; modulating immune cell signaling molecules proximate to the cancer cells; modulating the extracellular matrix surrounding the cancer cells; modulating resident host cells; modulating infiltrating host cells; modulating secreted factors proximate to the cancer cells; modulating the proteins surrounding the cancer cells; modulating the presence of pericycles proximate to the cancer cells; and modulating the presence of adipocytes proximate to the cancer cells.
BRIEF DESCRIPTION OF THE DRAWINGS [0023] Figure 1 is a schematic block diagram of a system for providing an alternating polarity (AP) magnetic field to a target body area of a patient’s body, according to one embodiment for selectively destroying cancer cells. [0024] Figure 2 is a front view of a retaining element comprising a bra having one or more AP electromagnetic coils for providing an AP magnetic field to breast tissue, according to one embodiment of the invention. [0025] Figure 3 is a front view of a retaining element comprising a hat including one or more AP electromagnetic coils for providing an AP magnetic field to brain tissue, according to one embodiment of the invention. [0026] Figure 4 is a front view of a retaining element comprising a shirt having one or more AP electromagnetic coils for providing an AP magnetic field to thoracic or abdominal tissue, according to one embodiment of the invention. [0027] Figure 5 is a front view of a retaining element comprising a neck cuff or collar having one or more AP electromagnetic coils for providing an AP magnetic field to a target area of a patient’s body, according to one embodiment of the invention. [0028] Figure 6 is a front view of a retaining element comprising a bandage having one or more AP electromagnetic coils for providing an AP magnetic field to a target area of a patient’s body, according to one embodiment of the invention. [0029] Figure 7A is a photograph at 10X magnification of untreated B16F10 mouse melanoma cells incubated for 24 hours. [0030] Figure 7B is a photograph of B16F10 mouse melanoma cells exposed to an AP magnetic field for 24 hours according to one embodiment of the invention. id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31"
[0031] Figure 8 is a bar graph showing the reduction in cell counts of B16F10 mouse melanoma cells treated with an AP magnetic field for 24 hours compared to untreated controls. [0032] Figure 9 is a graph of tumor volume as a function of time from the start of a magnetic field tumor therapy in an experiment according to one embodiment of the invention. [0033] Figure 10 is a schematic block diagram of one embodiment of a system for providing an alternating polarity (AP) magnetic field to a target body area of a patient’s body for treating cancer cells. [0034] Figure 11 is a table summarizing the results of a number of experiments on cancer cells using alternating polarity (AP) magnetic field tumor (MFT) therapy. [0035] Figure 12 is a graph showing the increase in tumor volume over time for breast cancer cells in an animal model experiment involving MFT therapy. [0036] Figure 13 is a graph showing the increase in tumor volume over time for colon cancer cells in animals treated with an immunotherapy alone or combined with MFT therapy. [0037] Figure 14 is a graph showing relative metastasis of breast cancer cells in animals treated with MFT therapy, an immunotherapy, or combined MFT therapy and immunotherapy. [0038] Figure 15 is a graph showing relative changes of CD8+ T cells in the tumor microenvironment of breast cancer cells in animals treated with MFT therapy, an immunotherapy, or combined MFT therapy and immunotherapy. [0039] Figure 16 is a graph showing relative changes of myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment of breast cancer cells in animals treated with MFT therapy, an immunotherapy, or combined MFT therapy and immunotherapy. [0040] Figure 17 is a graph showing relative changes of dendritic cells (DCs) in the tumor microenvironment of breast cancer cells in animals treated with MFT therapy, an immunotherapy, or combined MFT therapy and immunotherapy.

Claims (32)

CLAIMSWhat is claimed is:
1. A system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator and to a target body area, wherein the one or more electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller for controlling one or more of the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.05-5 mT, wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, eliciting an immune response to the cancer cells, increasing tumor immunogenicity, decreasing immunosuppressive activity of the cancer cells, recruiting one of antigen-presenting cells and immune effector cells to the tumor microenvironment, or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed.
2. The system of claim 1, wherein the cancer cells are one of brain cancer cells, breast cancer cells, lung cancer cells, lung carcinoid tumor cells, thymic cancer cells, tracheal cancer cells, pancreatic cancer cells, liver cancer cells, stomach cancer cells, kidney cancer cells, ovarian cancer cells, colon cancer cells, rectal cancer cells, prostate cancer cells, throat cancer cells, thyroid cancer cells, mouth cancer cells, nose cancer cells, and salivary gland cancer cells.
3. The system of claim 2 wherein the one or more AP electromagnetic coils are coupled to the target body area by a retaining element during the application of the AP magnetic field to the target body area.
4. The system of claim 3, wherein the cancer cells are breast cancer cells, and the retaining element is a wearable garment selected from a bra, a shirt, and a vest.
5. The system of claim 3, wherein the cancer cells are selected from lung cancer, lung carcinoid tumors, thymic malignancies, tracheal tumors, pancreatic cancer, liver cancer, stomach cancer, kidney cancer, ovarian cancer, colon cancer and rectal cancer, and the retaining element is a wearable garment selected from a bra, a shirt, a vest, and a jacket.
6. The system of claim 3, wherein the cancer cells are lower-body cancer cells selected from prostate cancer cells, ovarian cancer cells, colon cancer cells, and rectal cancer cells, and the retaining element is an undergarment.
7. The system of claim 3, wherein the cancer cells are brain cancer cells and the retaining element is a head covering selected from a hat, a helmet, and a garment head covering.
8. The system of claim 1 wherein the one or more AP electromagnetic coils are coupled to the target body area by a retaining element during the application of the AP magnetic field to the target body area.
9. The system of claim 9 wherein the retaining element is selected from a bra, a shirt, a vest, a jacket, an undergarment, and a bandage.
10. The system of claim 1, wherein the one or more AP electromagnetic coils comprise a plurality of electromagnetic coils coupled to the target body area to obtain a desired magnetic field distribution in the target body area.
11. The system of claim 1, further comprising: an electromagnetic shield for shielding at least one non-target body area of the patient’s body from exposure to the AP magnetic field.
12. A system for treating cancer cells in a target area of a patient’s body comprising: at least one electromagnetic coil coupled to a target body area; and a controller for controlling the at least one electromagnetic coil to generate and apply to the target body area an alternating polarity (AP) magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.05 - 5 mT, wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, eliciting an immune response to the cancer cells, increasing tumor immunogenicity, decreasing immunosuppressive activity of the cancer cells, recruiting one of antigen-presenting cells and immune effector cells to the tumor microenvironment (TME), or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed.
13. The system of claim 12, further comprising: a power supply for supplying power to said electromagnetic coil.
14. A system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; one or more AP electromagnetic coils coupled to the AP magnetic field generator and to a target body area, wherein the one or more electromagnetic coils are energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; a controller for controlling the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.1-5 mT, wherein the AP magnetic field modifies the cancer microenvironment (TME) by at least one of: increasing the number of CD8+ lymphocytes in the TME; increasing the ratio of CD8+ to total lymphocytes in the TME; increasing the number of CD4+ lymphocytes; increasing the ratio of CD4+ to total lymphocytes in the TME; increasing the number of tumor infiltrating lymphocytes (TILs) in the TME; increasing the number of antigen presenting cells (APCs) in the TME; increasing the concentration of tumor-suppressive cytokines in the TME; decreasing the concentration of tumor-promoting cytokines in the TME; increasing the number of M1 macrophages in the TME; decreasing the number of M2 macrophages in the TME; decreasing one of the number or concentration of myloid-derived suppressor cells (MDSCs) in the TME; and increasing one of the number or concentration of natural killer (NK) cells in the TME.
15. The system of claim 14, wherein the AP magnetic field further achieves at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, preventing metastasis of the cancer cells, and inhibiting angiogenesis for the cancer cells, while leaving non-cancer cells substantially unharmed.
16. The system of claim 14, wherein the AP magnetic field further achieves at least one additional modification of the TME selected from modulating the blood vessels surrounding the cancer cells, modulating the presence of fibroblasts proximate to the cancer cells, modulating immune cell signaling molecules proximate to the cancer cells, modulating the extracellular matrix surrounding the cancer cells, modulating resident host cells, modulating infiltrating host cells, modulating secreted factors proximate to the cancer cells, modulating the proteins surrounding the cancer cells, modulating the concentration of pericycles proximate to the cancer cells, and modulating the adipocytes proximate to the cancer cells.
17. The system of claim 14, wherein the one or more AP electromagnetic coils are maintained in close proximity to the target body area by a retaining element during the application of the AP magnetic field to the target body area, and wherein the retaining element is selected from a garment and a bandage.
18. The system of claim 17, wherein the AP magnetic field generator, the one or more AP electromagnetic coils, the retaining element, and the controller are each wearable by the user, and wherein the system comprises an ambulatory treatment system capable of providing treating the cancer cells while the patient is non-stationary.
19. The system of claim 14, wherein the one or more AP electromagnetic coils comprise a plurality of electromagnetic coils, and the retaining element is selected from a hat, a cap, a bra, a shirt, and a vest, and is adapted to maintain the plurality of electromagnetic coils in a desired position relative to the target body area.
20. The system of claim 14, wherein the controller comprises a timing control module to control the AP magnetic field generator and the one or more AP electromagnetic coils to perform at least one of: applying the AP magnetic field continuously to the target body area for a first treatment period; applying the AP magnetic field intermittently for a second treatment period in alternating on time periods in which the AP magnetic field is applied to the target body area, followed by off time periods in which the AP magnetic field is not applied to the target body area; applying the AP magnetic field intermittently for one or more circadian treatment periods based on circadian rhythms of the patient; and applying the AP magnetic field intermittently for one or more third treatment periods at defined times of day.
21. The system of claim 14, wherein the controller comprises: a frequency control module to control the AP magnetic field generator and the one or more AP electromagnetic coils to perform at least one of: applying an AP magnetic field having a single frequency of 1 - 500 kHz to the target body area; applying an AP magnetic field having a frequency of 1 - 500 kHz that varies in a defined pattern; applying an AP magnetic field having multiple simultaneous frequencies of 1 - 100 kHz; and applying an AP magnetic field having a bimodal magnetic field frequency distribution comprising a first variable AP magnetic field distribution that varies the magnetic field frequency between a first lower limit and a first upper limit and a second variable AP magnetic field distribution that varies the magnetic field frequency between a second lower limit and a second upper limit.
22. The system of claim 21, wherein the frequency control module further controls the AP magnetic field generator and the one or more electromagnetic coil to apply an AP magnetic field having at least one of: a frequency of 1 - 500 kHz that varies randomly; a frequency that varies in a Gaussian distribution in one or more ranges within the range of 1 - 500 kHz; a frequency that varies in a non-Gaussian distribution in one or more ranges within the range of 1 - 500 kHz.
23. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency within a frequency range selected from 0.2-400 kHz, 0.5-300 kHz, 1-200 kHz, 5-150 kHz, 10-100 kHz, and 25-1kHz, and a field strength within a field strength range selected from 0.2-5 mT; 0.2-4 mT; 0.4-3 mT; 0.5-2 mT. and 0.1-1.6 mT.
24. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.2 - 400 kHz and a field strength of 0.2-4 mT.
25. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 0.5 - 300 kHz and a field strength of 0.4-3 mT.
26. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 1.0 - 200 kHz and a field strength of 0.5-2 mT.
27. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 5.0 - 150 kHz and a field strength of 0.1-1.6 mT.
28. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 10.0-100 kHz and a field strength of 0.1-5 mT.
29. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field having a frequency of 25.0-100 kHz and a field strength of 0.1-5 mT.
30. The system of claim 14, wherein the controller controls the AP magnetic field generator and the one or more AP electromagnetic coils to generate and apply to the target body area an AP magnetic field comprise a series of pulse bursts, where each pulse in the pulse burst occurs at a pulse frequency of 0.01-1000 Hz and has a pulse duration of 0.1-5000 msec, and wherein each pulse in the pulse burse comprises a frequency of 0.1 - 500 kHz and a field strength of 0.1-5 mT.
31. A system for treating cancer cells in a target body area of a patient comprising: an alternating polarity (AP) magnetic field generator; at least one electromagnetic coil coupled to the AP magnetic field generator and to a target body area, wherein the at least one electromagnetic coil is energized by an electrical signal from the AP magnetic field generator to generate an AP magnetic field having at least a first frequency and a first field strength; and a controller for controlling the at least one electromagnetic coil and power supply to generate and apply to the target body area an AP magnetic field having a frequency of 0.1 - 500 kHz and a field strength of 0.1-5 mT, wherein the AP magnetic field modifies the cancer microenvironment (TME) by at least one of: modulating the blood vessels surrounding the cancer cells; modulating the presence of fibroblasts proximate to the cancer cells; modulating immune cell signaling molecules proximate to the cancer cells; modulating the extracellular matrix surrounding the cancer cells; modulating resident host cells; modulating infiltrating host cells; modulating secreted factors proximate to the cancer cells; modulating the proteins surrounding the cancer cells; modulating the presence of pericycles proximate to the cancer cells; and modulating the presence of adipocytes proximate to the cancer cells.
32. The system of claim 31, wherein the applied AP magnetic field further achieves at least one additional modification of the TME selected from increasing the number of CD8+ lymphocytes in the TME, increasing the ratio of CD8+ to total lymphocytes in the TME, increasing the number of CD4+ lymphocytes, increasing the ratio of CD4+ to total lymphocytes in the TME, increasing the number of tumor infiltrating lymphocytes (TILs) in the TME, increasing the number of antigen presenting cells (APCs) in the TME, increasing the concentration of tumor-suppressive cytokines in the TME, decreasing the concentration of tumor-promoting cytokines in the TME, increasing the number of Mmacrophages in the TME, decreasing the number of M2 macrophages in the TME, decreasing one of the number or concentration of myloid-derived suppressor cells (MDSCs) in the TME; and increasing one of the number or concentration of natural killer (NK) cells in the TME.
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