I-Corps: Noninvasive Wound Healing Using Pulsating Electromagnetic Fields (PEMFs)

I-Corps项目更广泛的影响/商业潜力是微创伤口愈合技术的发展。医院和疗养院获得性损伤，尤其是静脉淤积性溃疡和压疮，除了对直系亲属和医疗保健提供者造成影响外，还会对患者的精神、身体、社会和情感健康产生负面影响。老年人慢性溃疡的治疗大多是姑息性的，包括使用绷带或敷料，伤口可能需要数月至数年才能愈合。迄今为止，大多数利用血管或内皮细胞有丝分裂生长因子的潜在疗法尚未达到伤口再生或闭合的临床相关标准。基于可行性研究，脉冲电磁场（pemf）以微创的方式提供了治疗顽固性软组织伤口（如慢性褥疮）的前景。更好地了解pemf诱导的愈合可以为理解作用机制（MOA）和设计适当的实验提供必要的关键信息，从而为成功的监管申请提供途径，并将其作为有效的伤口愈合临床治疗方法。在目标组织中有效刺激最大限度、持续愈合的能力仍然是再生医学领域的一个重要目标，并为PEMF治疗提供了明确的机会。I-Corps项目的基础是开发一种有效、低成本、低频脉冲电磁场（LF-PEMF）产生愈合装置，供家庭护理和养老院专业人员用于治疗老年人的慢性溃疡。LF-PEMF可能只需要处方和简单的患者培训课程。不同的PEMF模式已被研究作为促进组织修复的潜在治疗工具，包括正弦交变、脉冲电磁、脉冲电场和旋转磁场。将体外培养的人脐静脉内皮细胞暴露于pemf中可以刺激新的血管生长（又称血管生成）。暴露于PEMF的生理活性取决于电流强度、磁场强度、脉冲频率和暴露时间等物理参数。新型lf - pemf“调谐”用于启动/维持血管生成可能导致临床治疗软组织伤口的能力，包括慢性皮肤溃疡。这项技术建立在现有的FDA批准的LF-PEMF设备的基础上，目前用于促进顽固性骨折的骨骼生长，并建议使用新的波形模式来支持软组织再生，特别是通过细胞应激反应信号通路促进再生。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of minimally invasive wound-healing technology. Hospital and nursing home acquired injuries, especially venous stasis ulcers and pressure sores, can negatively impact a patient’s mental, physical, social, and emotional well-being, in addition to being concerning to immediate family and healthcare providers. Treatment of chronic ulcers in the elderly is mostly palliative, involving application of bandages or dressings, and wounds can require months to years to heal. To date, most potential therapies utilizing vascular or endothelial mitogenic growth factors have not reached the clinically relevant criteria of wound regeneration or closure. Based upon feasibility studies, the Pulsating Electromagnetic Fields (PEMFs) offer the prospect of healing recalcitrant soft tissue wounds, such as chronic bed sores, in a minimally invasive manner. Better understanding of PEMF-induced healing may provide the critical information necessary for understanding the mechanism of action (MOA) and designing appropriate experiments, thus providing an avenue for successful regulatory filings and use as an effective clinical treatment for wound healing. The ability to efficiently stimulate maximal, sustained healing in targeted tissues remains a goal of importance to the field of regenerative medicine and provides a clear opportunity for PEMF therapy.This I-Corps project is based on the development of an effective, low-cost, low-frequency pulsed electromagnetic field (LF-PEMF) generating healing device for home care and nursing home professionals to use in the treatment of chronic ulcers in the elderly. The LF-PEMF may only require a prescription and a simple patient training session. Different PEMF modalities have been investigated as potential therapeutic tools for promoting tissue repair, including sinusoidal alternating, pulsed electromagnetic, pulsating electric, and rotating magnetic fields. Neww blood vessel growth (a.k.a. angiogenesis) can be stimulated by exposing in vitro cultured human umbilical vein endothelial cells to PEMFs. Physiological activity of exposure to PEMF depends upon the physical parameters of current intensity, magnetic field strength, pulse frequency, and exposure duration. The application of novel LF-PEMFs “tuned” to initiating/sustaining angiogenesis may result in the ability to clinically treat soft tissue wounds, including chronic skin ulcers. This technology builds upon existing Food and Drug Administration (FDA)-cleared LF-PEMF devices, currently used to promote bone growth in recalcitrant fractures and suggests applications for the use of novel waveform patterns to support soft tissue regeneration, specifically by promoting regeneration through cellular stress response signaling pathways.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.