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: 8137664
• 负责人: RICHARD Lee NUCCITELLI
• 金额: $ 92.19万
• 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 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8137664
• 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; Institutional Review Boards; Lesion; Malignant - descriptor; Medical Device; Melanoma Cell; Microprocessor; Monitor; Mus; Noise; Nude Mice; Operative Surgical Procedures; Patients; Physiologic pulse; Plastic Surgical Procedures; Procedures; Protocols documentation; Quality of life; Recurrence; Safety; Schedule; Skin; Skin Cancer; Skin Neoplasms; Suction; 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）：BioElectroMed正在开发一种名为PulseCure系统的新型医疗器械，该器械利用纳秒脉冲电场消除良性和恶性皮肤病变。我们已经使用PulseCure治疗小鼠恶性黑色素瘤和基底细胞癌，具有非常高的疗效。通过使用100 ns脉冲的单次6分钟治疗，我们可以在裸鼠中触发恶性黑色素瘤的完全缓解而不复发。在这6分钟的治疗期间，肿瘤仅暴露于电场总共200 μ s，但这刺激了固缩、凋亡、DNA片段化并减少了流向肿瘤的血流。这导致平均肿瘤大小在两周内消退90%，并在1个月内完全缓解。我们开发了一种新的抽吸电极设计，用于更厚的人类皮肤，并在小鼠模型上证明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输送系统，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引电极配置来优化脉冲参数，以最大限度地减少治疗时间，并对人体试验所需的PulseCure系统进行几项改进。这些改进包括减少电磁干扰，实现ANSI/AAMI ES60601-1和ES60601-2标准要求的安全功能，制造可调节臂以便于电极放置在人体上，开发计算机界面以记录患者和治疗数据，以及匹配电阻器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，治疗计划在整形手术过程中从患者身上去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，它将提供一种受欢迎的，非手术的，也许是无疤痕的手术替代方案，可以提高成千上万皮肤病患者的生活质量。 公共卫生相关性：我们正在开发一种新的医疗器械PulseCure，用于治疗良性和恶性皮肤病变。脉冲治疗使用超短电脉冲触发皮肤肿瘤自我毁灭。它提供了一种非手术治疗，可能是一个无疤痕，并可以提高生活质量的皮肤病患者数以万计。