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Autologous peripheral blood mononuclear cell-loaded injectable cell scaffold
(ICS-001) for revolutionising angiogenic therapy: a study protocol for an
exploratory clinical trial
#MMPMID41130688
Yamahara K
; Akahori H
; Kawai K
; Suna S
; Yoshihara S
; Ishihara M
; Kakibuchi M
; Furukawa M
; Kogai Y
; Sato H
; Fukumoto S
; Furuzono T
; Tani-Yokoyama A
; Okamoto R
; Fujita Y
; Kawamoto A
BMJ Open
2025[Oct]; 15
(10
): e107486
PMID41130688
show ga
INTRODUCTION: This research paper presents a study protocol for an exploratory
clinical trial evaluating the safety and potential efficacy of autologous
peripheral blood mononuclear cell (PBMNC)-loaded injectable cell scaffold
(ICS-001) for angiogenic therapy in chronic limb-threatening ischaemia (CLTI).
CLTI, the advanced stage of peripheral artery disease, presents significant
therapeutic challenges. METHODS AND ANALYSIS: Angiogenic therapy using ICS-001
with PBMNCs-a novel approach designed to enhance local cell retention and promote
neovascularisation-will be explored. The study will address the pathophysiology
of CLTI, the limitations of current treatments and the rationale for cell-based
therapies, alongside the clinical trial design for evaluating the safety and
efficacy of ICS-001. We hypothesise that ICS-001 will improve ulcer healing and
reduce ischaemic rest pain in patients with CLTI. This paper outlines the
methodology, including patient selection, CD34(+) cell mobilisation, scaffold
preparation, injection protocols, clinical assessments, data collection and
safety monitoring. The anticipated results, discussion and conclusion will offer
insight into the clinical significance and potential impact of ICS-001 as a
pioneering angiogenic therapy for CLTI. ETHICS AND DISSEMINATION: The
institutional review boards of all participating hospitals approved this study
protocol (latest version V.6.0, 5 June 2025). Final data will be made publicly
available. A report detailing the study results will be submitted for publication
in an appropriate peer-reviewed journal. DATA AVAILABILITY STATEMENT: Data are
available on reasonable request. Technical appendix, statistical code is
available by contacting the corresponding author. This is an open access article
distributed in accordance with the Creative Commons Attribution Non Commercial
(CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build
on this work non-commercially, and licence their derivative works on different
terms, provided the original work is properly cited, appropriate credit is given,
any changes made indicated and the use is non-commercial. See:
http://creativecommons.org/licenses/by-nc/4.0/ TRIAL REGISTRATION NUMBER:
jRCT2052230115, Japan Registry of Clinical Trials.
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