Implant-type Tissue-engineered Cartilage for Secondary Correction of Cleft Lip-nose Patients: An Exploratory First-in-human Trial
Kazuto Hoshi1,2*, Yuko Fujihara1, Hideto Saijo1, Yukiyo Asawa2, Satoru Nishizawa3, Sanshiro Kanazawa2, Sakura Uto2, Ryoko Inaki2, Mariko Matsuyama2, Tomoaki Sakamoto2, Makoto Watanabe2, Madoka Sugiyama1, Kazumichi Yonenaga1, Atsuhiko Hikita2 and Tsuyoshi Takato1,2
- *Corresponding Author:
- Kazuto Hoshi
Department of Sensory and Motor System Medicine, Graduate School of Medicine
The University of Tokyo, Hongo 7-3-1
Bunkyo-ku, Tokyo 113-8655, Japan
E-mail: [email protected]
Received date: June 07, 2017; Accepted date: June 20, 2017; Published date: June 24, 2017
Citation: Hoshi K, Fujihara Y, Saijo H, Asawa Y, Nishizawa S, et al. (2017) Implant-type Tissue-engineered Cartilage for Secondary Correction of Cleft Lip-nose Patients: An Exploratory First-in-human Trial. J Clin Trials 7:315. doi:10.4172/2167-0870.1000315
Copyright: © 2017 Hoshi K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Objective: Secondary correction of cleft lip-nose presents a formidable challenge in cleft lip and palate surgery. Although numerous approaches have been proposed, suitable graft materials cannot be obtained from any part of body or the artificial biomaterials. We have established implant-type tissue-engineered cartilage using a porous scaffold comprised of poly L-lactic acid. The aim of this study was to primarily assess the safety of the autologous tissue-engineered cartilage when used in the cleft lip-nose patients as an exploratory first-in-human trial, and to explore the usefulness of the cartilage.
Methods: After the acquisition of institutional and governmental permission, we used this implant-type tissueengineered cartilage for the treatment of three cleft lip-nose patients. We examined whether or not serious adverse events had occurred by which removal of the tissue-engineered cartilage was needed, 3 years after the transplantation. We also explored the usefulness of the cartilage, as aesthetic and functional outcomes.
Results: Each tissue-engineered cartilage fulfilled the defined release criteria for transplantation. The transplantation of the tissue-engineered cartilage in all the patients was performed just as planned. After 3 years of transplantation, we did not experience any serious adverse events that were related to the tissue-engineered cartilage. As a non-serious adverse event, calcification of the tissue-engineered cartilage was found in one patient. Nose shapes improved in all the patients, and more than 2 mm of nose augmentation maintained for 3 years postsurgery, as measured in cephalogram. Although the dysfunction in facial expression or playing sports had rather increased immediately after the transplantation, the inconvenience generally recovered or improved during the postsurgical course.
Conclusion: The implant-type tissue-engineered cartilage could safely reconstruct the nasal dorsum and apex of cleft lip-noses. This tissue-engineered cartilage possibly leads to effective correction of a severe cleft lip-nose deformity with aesthetic and functional improvement.