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

开发纳秒脉冲电场系统来治疗皮肤癌

• 批准号: 8003209
• 负责人: RICHARD Lee NUCCITELLI
• 金额: $ 77.39万
• 依托单位: BIOELECTROMED CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8003209
• 关键词: Apoptosis; Automation; Basal Cell Nevus Syndrome; Basal cell carcinoma; Benign; Blood flow; Cicatrix; Clinical; Clinical Trials; Computer Interface; DNA Fragmentation; Data; Dermatology; Development; Devices; Disease remission; Documentation; Electrodes; Electromagnetics; Excision; Feasibility Studies; Heating; Human; Hypersensitivity skin testing; Lesion; Malignant - descriptor; Medical Device; Microprocessor; Monitor; Mus; Noise; Nude Mice; Operative Surgical Procedures; Patients; Physiologic pulse; Plastic Surgical Procedures; Procedures; Protocols documentation; Quality of life; Recurrence; Research Ethics Committees; Safety; Schedule; Skin; Skin Cancer; Skin Neoplasms; Suction; Syndrome; System; Testing; Thick; Time; Treatment Efficacy; Work; arm; design; electric field; improved; melanoma; mouse model; nanosecond; pilot trial; prototype; public health relevance; response; skin lesion; treatment duration; tumor; volunteer; Apoptosis; Automation; Basal Cell Nevus Syndrome; Basal cell carcinoma; Benign; Blood flow; Cicatrix; Clinical; Clinical Trials; Computer Interface; DNA Fragmentation; Data; Dermatology; Development; Devices; Disease remission; Documentation; Electrodes; Electromagnetics; Excision; Feasibility Studies; Heating; Human; Hypersensitivity skin testing; Lesion; Malignant - descriptor; Medical Device; Microprocessor; Monitor; Mus; Noise; Nude Mice; Operative Surgical Procedures; Patients; Physiologic pulse; Plastic Surgical Procedures; Procedures; Protocols documentation; Quality of life; Recurrence; Research Ethics Committees; Safety; Schedule; Skin; Skin Cancer; Skin Neoplasms; Suction; Syndrome; System; Testing; Thick; Time; Treatment Efficacy; Work; arm; design; electric field; improved; melanoma; mouse model; nanosecond; pilot trial; prototype; public health relevance; response; skin lesion; treatment duration; tumor; volunteer

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.

描述（由申请人提供）：生物电机正在开发一种称为脉冲系统的新医疗设备，该设备利用纳秒脉冲电场消除了良性和恶性皮肤损伤。我们已经使用了脉冲来治疗非常高功效的小鼠中的恶性黑色素瘤和基底细胞癌。通过使用100 NS脉冲进行单个6分钟的治疗，我们可以触发裸鼠无复发的恶性黑色素瘤完全缓解。在这个6分钟的治疗期间，肿瘤仅暴露于200 5S的电场上，但这刺激了肿瘤，凋亡，DNA片段化并减少血液流向肿瘤。这会导致两周内平均肿瘤大小回归为90％，并在1个月内完全缓解。我们已经开发了一种新的吸力电极设计，用于在更厚的人类皮肤上使用，并证明了这种新设计在鼠标模型上的功效。我们还开发了一个微处理器控制的脉冲输送系统，以便于脉冲的临床试验。在这里，我们建议使用最有效的吸力构型优化脉冲参数，以最大程度地减少治疗时间，并对人类试验所需的脉冲系统进行一些改进。这些改进包括减少电磁干扰，实施ANSI/AAMI ES60601-1和ES60601-2标准所需的安全功能，制造可调节的手臂以促进对人类的电极放置，开发计算机接口，以记录患者和匹配的电阻器选择和火花选择和火花的选择和自动化的匹配器选择和火花隔离间距。然后，我们将进行一项可行性研究，以治疗计划在整容手术过程中从患者中切除的人皮以及基础细胞尿症综合征的志愿者的基础细胞癌。接下来，我们将对10例基底细胞云综合征患者进行一项试验临床试验，该试验治疗30个基底细胞癌。如果脉冲可以可靠地消除恶性皮肤病变，则可以为手术提供一种受欢迎的，非手术和无疤痕的替代品，可以改善成千上万的皮肤病学患者的生活质量。 公共卫生相关性：我们正在开发一种新的医疗设备，即脉冲，用于治疗良性和恶性皮肤病变。脉冲使用超时的电脉冲来触发皮肤肿瘤自我破坏。它提供了一种非手术疗法，可能是一种无疤痕的疗法，可以改善成千上万的皮肤病学患者的生活质量。