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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2022-07-08

AUTHORS

Yuuki Shimizu, Kazuhisa Kondo, Ryo Hayashida, Ken-ichiro Sasaki, Masanori Ohtsuka, Yoshihiro Fukumoto, Shinichiro Takashima, Oto Inoue, Soichiro Usui, Masayuki Takamura, Masashi Sakuma, Teruo Inoue, Tokuichiro Nagata, Yoshihiro J. Akashi, Yoshihiro Yamada, Tamon Kato, Koichiro Kuwahara, Kaoru Tateno, Yoshio Kobayashi, Rei Shibata, Toyoaki Murohara

ABSTRACT

BackgroundPatients 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.ObjectivesWe investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan.MethodsThe 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.ResultsThe 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 mm2 at to 109 mm2), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively.ConclusionsImplantation 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. More... »

PAGES

535-546

Journal

TITLE

Angiogenesis

ISSUE

4

VOLUME

25

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10456-022-09844-7

DOI

http://dx.doi.org/10.1007/s10456-022-09844-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1149335022

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/35802311


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16 schema:description BackgroundPatients 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.ObjectivesWe investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan.MethodsThe 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.ResultsThe 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 mm2 at to 109 mm2), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively.ConclusionsImplantation 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.
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