Outcome From a Randomized Controlled Clinical Trial　― Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT) ―

Horie, Takashi; Yamazaki, Seiji; Hanada, Sayaka; Kobayashi, Shuzo; Tsukamoto, Tatsuo; Haruna, Tetsuya; Sakaguchi, Katsuhiko; Sakai, Ken; Obara, Hideaki; Morishita, Kiyofumi; Saigo, Kenichi; Shintani, Yoshiaki; Kubo, Kohmei; Hoshino, Junichi; Oda, Teiji; Kaneko, Eiji; Nishikido, Masaharu; Ioji, Tetsuya; Kaneda, Hideaki; Fukushima, Masanori

doi:10.1253/circj.cj-17-1220

Cited by 16 publications

(11 citation statements)

References 26 publications

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“…It has been reported that one method among the cell therapies that promote peripheral circulation is therapeutic angiogenesis using bone marrow-derived mononuclear cells (BM-MNC). [8][9][10] The first clinical pilot study, Therapeutic Angiogenesis by Cell Transplantation (TACT) study, investigated this in CLI patients in 2002, 11 and subsequently, several studies have reported the safety and efficacy of BM-MNC implantation for CLI patients. 12,13 Randomized studies have reported that this cell therapy could lead to significant improvements in limb ischemia, thus extending amputation-free intervals and survival rates.…”

Section: Study Populationmentioning

confidence: 99%

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Kudoh

Yanishi

Yoshimi

et al. 2019

Circ J

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CD, particularly with systemic sclerosis (SSc, scleroderma) have experienced Raynaud's phenomenon or digital ulcers (DU) because of inadequate peripheral blood supply. Intractable ischemic ulcers negatively affect patients' quality of life (QOL), and may lead to limb amputation. 2 The European League against Rheumatism (EULAR) recommends intravenous (IV) iloprost, PDE-5 inhibitors, and C ritical limb ischemia (CLI) is caused by chronic arterial obstruction, mainly caused by arteriosclerosis obliterans (ASO), thromboangiitis obliterans (TAO), and collagen disease (CD). Patients with CLI often require limb amputation when conventional revascularization methods such as bypass surgery or endovascular treatment (EVT) fail or are not indicated. 1 Patients with

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Section: Study Populationmentioning

confidence: 99%

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Kudoh

Yanishi

Yoshimi

et al. 2019

Circ J

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“…In these so-called no-option CLI (NO-CLI) patients, the prognosis appears to be even worse, with a major amputation rate of 40% at 6 months from onset [2]. Novel approaches of stem cell-based therapeutic angiogenesis, including bone marrow- (BM) or peripheral blood (PB)-derived mononuclear cell (MNC) transplantation with or without purification of specific cell types, are increasingly being used in clinical trials that attempt to treat NO-CLI [5–13]. These phase I/II trials have confirmed the safety and feasibility of MNC transplantation and revealed its potential therapeutic benefits.…”

Section: Introductionmentioning

confidence: 99%

Predictors of responders to mononuclear stem cell-based therapeutic angiogenesis for no-option critical limb ischemia

et al. 2019

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BackgroundAlthough the mononuclear cell (MNC) transplantation could theoretically induce therapeutic angiogenesis in the patients with no-option critical limb ischemia (NO-CLI), the clinical responses to this approach are inconsistent among different clinical trials. The purpose of this study was to identify the prognostic factors of responders and develop a predictive nomogram to guide patient selection.MethodsWe retrospectively reviewed a consecutive NO-CLI cohort who received peripheral blood-derived transplantation in our center. The patients who survived and achieved complete remission of CLI at 6 months post-transplantation were defined as responders. Logistic regression models were used to screen and identify the prognostic factors based on which predictive nomogram was developed. A receiver operating characteristic (ROC) curve and a calibration curve were drawn to determine the discrimination level and predictive accuracy.ResultsThe study ultimately enrolled 103 patients, including 58 responders and 45 non-responders. Based on the multivariate regression analysis, age ≥ 50 years (odds ratio [OR] 0.201, P = 0.004), blood fibrinogen > 4 g/L (OR 0.176, P = 0.003), arterial occlusion above the knee/elbow (OR 0.232, P = 0.010), the transcutaneous pressure of oxygen (TcPO2) (OR 1.062, P = 0.006), and the Log total transplanted CD34+ cell count (OR 3.506, P = 0.046) were identified as independent prognostic factors of the responders in the nomogram. An area under the ROC curve of 0.851 indicated good discrimination, and the calibration curve of the predicted probability showed optimal agreement with that of the observed probability.ConclusionsAge, blood fibrinogen, arterial occlusion level, TcPO2, and the total transplanted CD34+ cell count were independent prognostic factors of the responders. A nomogram with high discrimination and accuracy was developed to provide individualized predictions.Trail registrationChiCTR, ChiCTR1800019401. Registered 9 November 2018—Retrospectively registeredElectronic supplementary materialThe online version of this article (10.1186/s13287-018-1117-5) contains supplementary material, which is available to authorized users.

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“…Ozturk et al (57) reported better improvement of Fontaine score, ABI, TcPO2, and pain score in diabetic CLI patients treated with G-CSF mobilized PBMNC compared to control subjects treated with stand-ard of care. Additionally, a more recent larger-scale randomized clinical trial by Horie et al (87) using G-CSF mobilized PBMNC transplantation showed that PBMNC therapy was able to significantly improve the progressionfree survival of mild-to-moderate PAD.…”

Section: Clinical Trials Of Stem Cell Therapy For Pad In Diabetes Patmentioning

confidence: 99%

Autologous Bone-Marrow vs. Peripheral Blood Mononuclear Cells Therapy for Peripheral Artery Disease in Diabetic Patients

Yunir

Kurniawan

Rezaprasga

et al. 2021

IJSC

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Diabetes mellitus (DM) remains one of the most important risk factors for peripheral artery disease (PAD), with approximately 20% of DM patients older than 40 years old are affected with PAD. The current standard management for severe PAD is endovascular intervention with or without surgical bypass. Unfortunately, up to 40% of patients are unable to undergo these revascularization therapies due to excessive surgical risk or adverse vascular side effects. Stem cell therapy has emerged as a novel therapeutic strategy for these ‘no-option’ patients. Several types of stem cells are utilized for PAD therapy, including bone marrow mononuclear cells (BMMNC) and peripheral blood mononuclear cells (PBMNC). Many studies have reported the safety of BMMNC and PBMNC, as well as its efficacy in reducing ischemic pain, ulcer size, pain-free walking distance, ankle-brachial index (ABI), and transcutaneous oxygen pressure (TcPO2). However, the capacity to establish the efficacy of reducing major amputation rates, amputation free survival, and all-cause mortality is limited, as shown by several randomized placebo-controlled trials. The present literature review will focus on comparing safety and efficacy between BMMNC and PBMNC as cell-based management in diabetic patients with PAD who are not suitable for revascularization therapy.

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Outcome From a Randomized Controlled Clinical Trial　― Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT) ―

Cited by 16 publications

References 26 publications

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Predictors of responders to mononuclear stem cell-based therapeutic angiogenesis for no-option critical limb ischemia

Autologous Bone-Marrow vs. Peripheral Blood Mononuclear Cells Therapy for Peripheral Artery Disease in Diabetic Patients

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Outcome From a Randomized Controlled Clinical Trial ― Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT) ―

Cited by 16 publications

References 26 publications

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma ― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma ― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Predictors of responders to mononuclear stem cell-based therapeutic angiogenesis for no-option critical limb ischemia

Autologous Bone-Marrow vs. Peripheral Blood Mononuclear Cells Therapy for Peripheral Artery Disease in Diabetic Patients

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Resources

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Outcome From a Randomized Controlled Clinical Trial　― Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT) ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―

Impact of Therapeutic Angiogenesis Using Autologous Bone Marrow-Derived Mononuclear Cells Implantation in Critical Limb Ischemia With Scleroderma　― Subanalysis of the Long-Term Clinical Outcomes Survey ―