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

1-12

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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8 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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12 schema:keywords BackgroundPatients
13 ConclusionsImplantation
14 Japan
15 ObjectivesWe
16 QOL scores
17 Rating Scale
18 achievement
19 adipose-derived regenerative cells
20 adverse events
21 amputation
22 angiogenesis
23 angiogenic potential
24 autologous adipose-derived regenerative cells
25 cell transplantation
26 cells
27 clinical trials
28 conventional options
29 critical limb ischemia
30 date
31 decrease
32 distance
33 efficacy
34 efficacy evaluation
35 endpoint
36 evaluation
37 events
38 feasibility
39 high rate
40 implantation
41 ischemia
42 ischemic limbs
43 life
44 life prognosis
45 limb
46 limb amputation
47 limb ischemia
48 limb salvage
49 lower limb amputation
50 major adverse events
51 major amputation
52 months
53 multicenter clinical trial
54 multicenter setting
55 multicenter trial
56 numerical rating scale
57 open-label study
58 optimal survival rates
59 option critical limb ischemia
60 options
61 overall survival rate
62 patients
63 period
64 point
65 poor life prognosis
66 post-operative period
67 potential
68 primary endpoint
69 prognosis
70 quality
71 quality of life
72 rate
73 regenerative cells
74 results
75 revascularization therapy
76 safety
77 salvage
78 scale
79 scores
80 setting
81 size
82 study
83 survival rate
84 therapeutic angiogenesis
85 therapy
86 time points
87 transplantation
88 trials
89 ulcer size
90 walking distance
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