DEVELOPMENT OF A NANOSECOND PULSED ELECTRIC FIELD SYSTEM TO TREAT SKIN CANCER

描述(申请人提供)：BioElectrMed正在开发一种名为PulseCure系统的新医疗设备，该设备利用纳秒脉冲电场来消除良性和恶性皮肤病变。我们已经用PulseCure治疗了小鼠的恶性黑色素瘤和基底细胞癌，疗效非常高。通过使用100 ns的脉冲进行一次6分钟的治疗，我们可以触发恶性黑色素瘤的完全缓解，而不会在裸鼠身上复发。在这6分钟的治疗期间，肿瘤只暴露在总共200 5s的电场中，但这会刺激固缩、细胞凋亡、DNA片段化和减少流向肿瘤的血液。这导致平均肿瘤大小在两周内缩小90%，并在1个月内完全缓解。我们已经开发了一种新的吸气电极设计，用于更厚的人类皮肤，并在小鼠模型上展示了这种新设计的有效性。我们还开发了一种微处理器控制的脉冲给药系统，便于在PulseCure的临床试验中使用。在这里，我们建议使用最有效的吸入电极配置来优化脉冲参数，以最大限度地减少治疗时间，并对PulseCure系统进行多项改进，以满足人体试验的需要。这些改进包括减少电磁干扰，实施ANSI/AAMIES60601-1和ES60601-2标准所要求的安全特性，制造便于在人体上放置电极的可调臂，开发用于记录患者和治疗数据的计算机界面，以及匹配电阻选择和火花间隙间距的自动化。然后，我们将进行一项可行性研究，治疗整形手术中患者预定切除的人类皮肤，以及患有基底细胞痣综合征的志愿者的基底细胞癌。接下来，我们将对10例基底细胞痣综合征患者进行30例基底细胞癌的初步临床试验。如果PulseCure能够可靠地消除恶性皮肤病变，它将为手术提供一种受欢迎的、非手术的、或许是无疤痕的替代方案，可以改善数万名皮肤病患者的生活质量。 公共卫生意义：我们正在开发一种新的医疗设备，PulseCure，用于治疗良性和恶性皮肤病变。PulseCure使用超短电脉冲来触发皮肤肿瘤自毁。它提供了一种非手术疗法，可能是一种无疤痕的疗法，可以改善数万名皮肤病患者的生活质量。

DESCRIPTION (provided by applicant): BioElectroMed is developing a new medical device called the PulseCure System that utilizes nanosecond pulsed electric fields to eliminate both benign and malignant skin lesions. We have used the PulseCure to treat malignant melanoma and basal cell carcinoma in mice with very high efficacy. With a single, 6-minute treatment using 100 ns pulses, we can trigger complete remission of malignant melanomas without recurrence in nude mice. During this 6 minute treatment period the tumor is only exposed to the electric field for total of 200 5s yet this stimulates pyknosis, apoptosis, DNA fragmentation and reduces blood flow to the tumor. This results in a mean tumor size regression of 90% within two weeks and complete remission within 1 month. We have developed a new suction electrode design for use on much thicker human skin and have demonstrated the efficacy of this new design on the mouse model. We also developed a microprocessor-controlled pulse delivery system for easy use in the clinical trials of the PulseCure. Here we propose to optimize the pulse parameters using the most effective suction electrode configuration to minimize treatment time and make several improvements to the PulseCure system necessary for human trials. These improvements include reducing electromagnetic interference, implementing safety features required by the ANSI/AAMI ES60601-1 and ES60601-2 standards, fabricating an adjustable arm to facilitate electrode placement on humans, developing a computer interface to record both patient and treatment data and automation of matching resistor selection and spark gap spacing. We will then conduct a feasibility study treating human skin scheduled for removal from patients during a plastic surgery procedure as well as Basal Cell Carcinomas on volunteers with Basal Cell Nevus Syndrome. Next we will conduct a Pilot Clinical Trial treating 30 basal cell carcinomas on 10 patients with Basal Cell Nevus Syndrome. If the PulseCure can reliably eliminate malignant skin lesions, it would offer a welcome, non-surgical and perhaps scar-free alternative to surgery that could improve the quality of life for tens of thousands of dermatology patients. PUBLIC HEALTH RELEVANCE: We are developing a new medical device, the PulseCure, for treating both benign and malignant skin lesions. The PulseCure uses ultrashort electrical pulses to trigger skin tumors to self- destruct. It offers a non-surgical therapy that may be a scar-free and could improve the quality of life for tens of thousands of dermatology patients.