Long-Term Outcome of Therapeutic Neovascularization Using Peripheral Blood Mononuclear Cells for Limb Ischemia

Moriya, Junji; Minamino, Tohru; Tateno, Kaoru; Shimizu, Naomi; Kuwabara, Yoichi; Sato, Yasunori; Saitō, Yasushi; Komuro, Issei

doi:10.1161/circinterventions.108.799361

Cited by 78 publications

(59 citation statements)

References 33 publications

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“…[1][2][3][5][6][7][8][9]22,23 Unfortunately, there have been only a few studies on long-term follow-up of clinical symptoms and outcomes, including major amputation, for more than 2 years after cell therapy. 4,15,24,25 These studies also clearly showed that cell therapy reduces the rate of major amputation, one of the primary end points. In addition, there has been no information on predictors of major amputation with BM-MNC implantation.…”

Section: Discussionmentioning

confidence: 89%

Autologous Bone-Marrow Mononuclear Cell Implantation Reduces Long-Term Major Amputation Risk in Patients With Critical Limb Ischemia

Idei

Soga

Hata

et al. 2011

Circ: Cardiovascular Interventions

128

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Background-Bone-marrow mononuclear cell (BM-MNC) implantation improves ischemic symptoms in patients withcritical limb ischemia (CLI). The purpose of this study was to evaluate long-term clinical outcomes after autologous BM-MNC implantation in patients with CLI. Methods and Results-We assessed long-term clinical outcomes after BM-MNC implantation in 51 patients with CLI, including 25 patients with peripheral arterial disease (PAD) and 26 patients with Buerger disease. Forty-six CLI patients who had no BM-MNC implantation served as control subjects. Median follow-up period was 4.8 years. The 4-year amputation-free rates after BM-MNC implantation were 48% in PAD patients and 95% in Buerger disease, and they were 0% in control PAD patients and 6% in control Buerger disease. The 4-year overall survival rates after BM-MNC implantation were 76% in PAD patients and 100% in Buerger disease, and they were 67% in control PAD patients and 100% in control Buerger disease. Multivariable Cox proportional hazards analysis revealed that BM-MNC implantation correlated with prevention of major amputation and that hemodialysis and diabetes mellitus correlated with major amputation. In Buerger disease, ankle brachial pressure index and transcutaneous oxygen pressure were significantly increased after 1 month and remained high during 3-year follow-up. However, in patients with PAD, ankle brachial pressure index and transcutaneous oxygen pressure significantly increased after 1 month and gradually decreased during 3-year follow-up and returned to baseline levels. Conclusions-These

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Section: Discussionmentioning

confidence: 89%

Autologous Bone-Marrow Mononuclear Cell Implantation Reduces Long-Term Major Amputation Risk in Patients With Critical Limb Ischemia

Idei

Soga

Hata

et al. 2011

Circ: Cardiovascular Interventions

128

View full text Add to dashboard Cite

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“…Many studies using different methods, such as vascular endothelial growth factor (VEGF)‐related gene transfer 6, 7, bone‐marrow mononuclear cell (BMMNC) 8, 9, 10, 11, 12, PBMNC 13, 14, 15, 16, 17, 18, or CD34+ cell 2, 3, 4 transplantation, have been completed and have proven their safety and efficacy. The long‐term outcome after CD34+ cell therapy in CLI patients was already reported by Kinoshita et al in 2012 19.…”

Section: Discussionmentioning

confidence: 99%

A Five-Year Study of the Efficacy of Purified CD34+ Cell Therapy for Angiitis-Induced No-Option Critical Limb Ischemia

Fang

Wei

Chen

et al. 2018

Stem Cells Translational Medicine

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Angiitis‐induced critical limb ischemia (AICLI) patients constitute a remarkable proportion of no‐option critical limb ischemia (CLI) patients. Stem cell therapy has become an innovative and promising option for no‐option CLI patients. As one of these promising stem cell therapies, purified CD34+ cell transplantation (PuCeT) has shown favorable short‐term results. However, the long‐term efficacy of PuCeT has yet to be reported. This study evaluates the long‐term efficacy of PuCeT in AICLI patients. Twenty‐seven AICLI patients were enrolled from May 2009 to December 2011. Granulocyte colony‐stimulating factor (G‐CSF) and enoxaparin sodium were administered for 5 days. On day 5, CD34+ cell isolation was performed, and cells were transplanted by intramuscular injection. The primary endpoint, major‐amputation‐free survival rate (MAFS), as well as secondary endpoints, such as peak pain‐free walking time (PPFWT) and the Wong‐Baker FACES pain rating scale score (WFPRSS), were routinely evaluated during the 5‐year follow‐up period. The endpoints were as follows: the MAFS was 88.89%; PPFWT increased from 3 ± 3 to 17 ± 6 minutes; WFPRSS decreased from 7 ± 2 to 0.3 ± 1.7; the ulcer healing rate was 85.71%; the recurrence rate was 11.11%; and SF‐36v2 scores were significantly improved at 5 years after PuCeT. The rate of labor recovery 5 years after PuCeT was 65.38%, and no severe adverse effect was observed during the treatment. PuCeT demonstrated long‐term efficacy and durability as a treatment of AICLI not only in achieving limb salvage but also in recovering the labor competence and improving the quality of life of patients. Stem Cells Translational Medicine 2018;7:583–590

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“…Critical limb ischemia (CLI) is the most advanced stage of PAD. It often coincides with ischemic ulceration and/or gangrene [1], and significantly decreases a patient’s quality of life. It is difficult to manage using current treatment modalities.…”

Section: Introductionmentioning

confidence: 99%

RETRACTED ARTICLE: Stromal vascular fraction cells for the treatment of critical limb ischemia: a pilot study

et al. 2017

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BackgroundCell-based therapy is being explored as an alternative treatment option for critical limb ischemia (CLI), a disease associated with high amputation and mortality rates and poor quality of life. However, therapeutic potential of uncultured adipose-derived stromal vascular fraction (SVF) cells has not been evaluated as a possible treatment. In this pilot study, we investigated the efficacy of multiple injections of autologous uncultured adipose-derived SVF cells to treat patients with CLI.MethodsThis study included 15 patients, from 35 to 77 years old, with rest pain and ulceration. SVF cells were injected once or twice in the ischemic limb along the arteries. Digital subtraction angiography was performed before and after cell therapy. The clinical follow up was carried out for the subsequent 12 months after the beginning of the treatment.ResultsMultiple intramuscular SVF cell injections caused no complications during the follow-up period. Clinical improvement occurred in 86.7% of patients. Two patients required major amputation, and the amputation sites healed completely. The rest of patients achieved a complete ulcer healing, pain relief, improved ankle-brachial pressure index and claudication walking distance, and had ameliorated their quality of life. Digital subtraction angiography performed before and after SVF cell therapy showed formation of numerous vascular collateral networks across affected arteries.ConclusionResults of this pilot study demonstrate that the multiple intramuscular SVF cell injections stimulate regeneration of injured tissue and are effective alternative to achieve therapeutic angiogenesis in CLI patients who are not eligible for conventional treatment.Trial registration number at ISRCTN registry, ISRCTN13001382. Retrospectively registered at 26/04/2017.

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Long-Term Outcome of Therapeutic Neovascularization Using Peripheral Blood Mononuclear Cells for Limb Ischemia

Cited by 78 publications

References 33 publications

Autologous Bone-Marrow Mononuclear Cell Implantation Reduces Long-Term Major Amputation Risk in Patients With Critical Limb Ischemia

Autologous Bone-Marrow Mononuclear Cell Implantation Reduces Long-Term Major Amputation Risk in Patients With Critical Limb Ischemia

A Five-Year Study of the Efficacy of Purified CD34+ Cell Therapy for Angiitis-Induced No-Option Critical Limb Ischemia

RETRACTED ARTICLE: Stromal vascular fraction cells for the treatment of critical limb ischemia: a pilot study

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