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

这个i-Corps项目的更广泛的影响/商业潜力是微创伤口愈合技术的开发。医院和疗养院获得性损伤，特别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的担忧外，还会对患者的心理、身体、社交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治疗，包括使用绷带或敷料，伤口可能需要几个月到几年的时间才能愈合。到目前为止，大多数利用血管或内皮有丝分裂生长因子的潜在治疗方法还没有达到伤口再生或闭合的临床相关标准。根据可行性研究，脉动电磁场(PEMF)有望以微创的方式治愈顽固性软组织伤口，如慢性压疮。更好地了解PEMF诱导的愈合可能为理解作用机制(MOA)和设计适当的实验提供必要的关键信息，从而为成功地提交调控文件并用作伤口愈合的有效临床治疗提供途径。有效地刺激目标组织最大限度、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治疗提供了一个明确的机会。这个i-Corps项目基于开发一种有效、低成本、低频脉冲电磁场(LF-PEMF)产生愈合设备的家庭护理和疗养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模式已被研究为促进组织修复的潜在治疗工具，包括正弦交变磁场、脉冲电磁、脉动电场和旋转磁场。NeWW血管生长(又名血管生成)可以通过将体外培养的人脐静脉内皮细胞暴露于PEMFS来刺激。PEMF暴露的生理活性取决于电流强度、磁场强度、脉冲频率和暴露持续时间等物理参数。新型LF-PEMFS在启动/维持血管生成方面的应用可能导致临床治疗软组织创伤，包括慢性皮肤溃疡。这项技术建立在食品和药物管理局(FDA)批准的现有LF-PEMF设备的基础上，目前该设备用于促进顽固性骨折的骨生长，并建议应用新的波形模式支持软组织再生，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NSF的法定使命，并通过使用基金会的智力优势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.