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Therapeutic angiogenesis for patients with no-option critical limb ischemia by adipose-derived regenerative cells: TACT-ADRC multicenter trial

BACKGROUND: Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients wi...

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Detalles Bibliográficos
Autores principales: Shimizu, Yuuki, Kondo, Kazuhisa, Hayashida, Ryo, Sasaki, Ken-ichiro, Ohtsuka, Masanori, Fukumoto, Yoshihiro, Takashima, Shinichiro, Inoue, Oto, Usui, Soichiro, Takamura, Masayuki, Sakuma, Masashi, Inoue, Teruo, Nagata, Tokuichiro, Akashi, Yoshihiro J., Yamada, Yoshihiro, Kato, Tamon, Kuwahara, Koichiro, Tateno, Kaoru, Kobayashi, Yoshio, Shibata, Rei, Murohara, Toyoaki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9263817/
https://www.ncbi.nlm.nih.gov/pubmed/35802311
http://dx.doi.org/10.1007/s10456-022-09844-7
Descripción
Sumario:BACKGROUND: Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients with limb ischemia. OBJECTIVES: We investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan. METHODS: The TACT-ADRC multicenter trial is a prospective, interventional, open-labeled study. Patients with CLI (Fontaine class III–IV) who have no other option for standard revascularization therapy were enrolled in this study. Thirty-four target ischemic limbs of 29 patients were received freshly isolated autologous ADRCs implantation. RESULTS: The overall survival rate at a post-operative period and at 6 months follow-up was 100% at any time points. As a primary endpoint for efficacy evaluation, 32 limbs out of 34 (94.1%) were free from major amputation for 6 months. Numerical rating scale (from 6 to 1) as QOL score, ulcer size (from 317 mm(2) at to 109 mm(2)), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively. CONCLUSIONS: Implantation of autologous ADRCs could be safe and effective for the achievement of therapeutic angiogenesis in the multicenter settings, as a result in no major adverse event, optimal survival rate, and limb salvage for patients with no-conventional option against critical limb ischemia. TRN: jRCTb040190118; Date: Nov. 24th, 2015. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10456-022-09844-7.