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Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study

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Abstract

Background

Based on the volume of tissue removed, conservative surgery (BCS) cannot always guarantee satisfactory cosmetic results, unless resorting to more complex oncoplastic approaches. Investigating an alternative to optimize aesthetic outcomes minimizing surgical complexity, was the purpose of this study. We assessed an innovative surgical procedure based on the use of a biomimetic polyurethane-based scaffold intended for regenerating soft-tissue resembling fat, in patients undergoing BCS for non-malignant breast lesions. Safety and performance of the scaffold, and safety and feasibility of the entire implant procedure were evaluated.

Methods

A volunteer sample of 15 female patients underwent lumpectomy with immediate device positioning, performing seven study visits with six-month follow-up. We evaluated incidence of adverse events (AEs), changes in breast appearance (using photographs and anthropomorphic measurements), interference with ultrasound and MRI (assessed by two independent investigators), investigator’s satisfaction (through a VAS scale), patient’s pain (through a VAS scale) and quality of life (QoL) (using the BREAST-Q© questionnaire). Data reported are the results of the interim analysis on the first 5 patients.

Results

No AEs were device related nor serious. Breast appearance was unaltered and the device did not interference with imaging. High investigator’s satisfaction, minimal post-operative pain and positive impact on QoL were also detected.

Conclusions

Albeit on a limited number of patients, data showed positive outcomes both in terms of safety and performance, paving the way to an innovative breast reconstructive approach with a potential remarkable impact on clinical application of tissue engineering.

Trial registration

ClinicalTrials.gov (NCT04131972, October 18, 2019).

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Data availability

The data presented in this study are available on request from the corresponding author.

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Acknowledgements

Authors kindly acknowledge all the colleagues and the operating room staff for organizational and technical support. Authors acknowledge support from the European Commission with the grant H2020-EIC-SMEInst-2018–2020 (Grant agreement number: 812002).

Author information

Authors and Affiliations

  1. Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy

    Maria Donatella Mariniello, Matteo Ghilli, Livio Colizzi, Maria Ghilardi & Manuela Roncella

  2. Breast Radiology, Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy

    Benedetta Favati & Maria Cristina Cossu

  3. Tensive SRL, Via Timavo 34, Milan, Italy

    Irini Gerges, Margherita Tamplenizza, Alessandro Tocchio & Federico Martello

  4. Department of Civil and Industrial Engineering, University of Pisa, Largo L. Lazzarino 2, 56122, Pisa, Italy

    Serena Danti

  5. Department of Civil and Environmental Engineering, Massachusetts Institute of Technology, 77 Massachusetts Ave., Cambridge, MA, 02139, USA

    Serena Danti

Authors
  1. Maria Donatella Mariniello
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  2. Matteo Ghilli
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  3. Benedetta Favati
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  4. Irini Gerges
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  7. Alessandro Tocchio
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by MDM, BF, IG, MT, AT, FM, MG, and MR. The first draft of the manuscript was written by MDM and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Maria Donatella Mariniello.

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Conflict of interest

The authors declare the following financial/non-financial interests which may be considered as potential competing interests: Authors I.G., M.T., A.T. and F.M. are share-holders and members of the board of directors of Tensive S.r.l. They have received the grant H2020-EIC-SMEInst-2018–2020 (Grant agreement number: 812002) from the European Commission. The remaining authors have no relevant financial or non-financial interests to disclose.

Ethical approval

This study involving human participants, was conducted in accordance with the ethical standards of the institutional (AOUP Ethical Committee-Protocol # 51965, 11 October 2018) and national (Italian Ministry of Health-0066926-05/12/2018-DGDMF-MDS-P) research committee and with the 1964 Helsinki declaration and its later amendments and the Good Clinical Practice principles.

Informed consent

Written informed consent was obtained from all individual participants included in the study.

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Mariniello, M.D., Ghilli, M., Favati, B. et al. Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study. Breast Cancer 30, 559–569 (2023). https://doi.org/10.1007/s12282-023-01446-5

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