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Published on: September 17, 2013
First-in-human trial of nanoelectroablation therapy for basal cell carcinoma: proof of method
Richard Nuccitelli1, Ryan Wood, Mark Kreis
1BioElectroMed Corp., Burlingame, CA, USA.
Abstract:
This nanoelectroablation therapy effectively treats subdermal murine allograft tumors, autochthonous basal cell carcinoma (BCC) tumors in Ptch1+/-K14-Cre-ER p53 fl/fl mice, and UV-induced melanomas in C57/BL6 HGF/SF mice. Here, we described the first human trial of this modality. We treated 10 BCCs on three subjects with 100-1000 electric pulses 100 ns in duration, 30 kV/cm in amplitude, applied at 2 pulses per second. Seven of the 10 treated lesions were completely free of basaloid cells when biopsied and two partially regressed. Two of the 7 exhibited seborrheic keratosis in the absence of basaloid cells. One of the 10 treated lesions recurred by week 10 and histologically had the appearance of a squamous cell carcinoma. No scars were visible at the healed sites of any of the successfully ablated lesions. One hundred pulses were sufficient for complete ablation of BCCs with a single, 1-min nanoelectroablation treatment.
Insights
Nanoelectroablation therapy shows promise for treating basal cell carcinoma (BCC). A human trial demonstrated complete ablation of most BCC lesions with minimal scarring and no recurrence in successfully treated sites.
Area of Science:
- Oncology
- Dermatology
- Biomedical Engineering
Background:
- Basal cell carcinoma (BCC) is a common skin cancer.
- Existing treatments can cause scarring and side effects.
- Nanoelectroablation is a novel therapeutic modality.
Purpose of the Study:
- To evaluate the safety and efficacy of nanoelectroablation for treating human BCC.
- To determine optimal treatment parameters for BCC ablation.
Main Methods:
- A first-in-human trial treated 10 BCC lesions on three subjects.
- Treatment involved 100-1000 electric pulses (100 ns duration, 30 kV/cm amplitude, 2 Hz).
- Lesions were biopsied post-treatment to assess for residual basaloid cells.
Main Results:
- Seven of 10 treated BCC lesions showed complete ablation of basaloid cells.
- Two lesions partially regressed, and one recurred as squamous cell carcinoma.
- No visible scarring was observed at healed sites.
- 100 pulses (1-minute treatment) were sufficient for complete ablation.
Conclusions:
- Nanoelectroablation is a safe and effective treatment for human BCC.
- The therapy offers potential for scar-free tumor removal.
- Further investigation is warranted to optimize treatment protocols and long-term outcomes.

