Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial

Tateishi-Yuyama, Eriko; Matsubara, Hiroaki; Murohara, Toyoaki; Ikeda, Uichi; Shintani, Satoshi; Masaki, Hiroya; Amano, Katsuya; Kishimoto, Yuji; Yoshimoto, Kohji; Akashi, Hidetoshi; Shimada, Kazuyuki; Iwasaka, Toshiji; Imaizumi, Tsutomu

doi:10.1016/s0140-6736(02)09670-8

Cited by 1,597 publications

(1,248 citation statements)

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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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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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“…Results of the first clinical study in CLI patients were published as early as 5 years after the description of EPC [9] (Table 1a). Since 2002, there has been a steady rise in the number of clinical reports, currently accumulating to at least 39 (including 775 patients) (Table 1a-c).…”

Section: Clinical Study Overview and General Trendsmentioning

confidence: 99%

Emerging hurdles in stem cell therapy for peripheral vascular disease

2008

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Indeed, while questions about safety, dose and administration route/timing/frequency are the first ones to be addressed when designing a stem-cell based clinical approach, there is accumulating evidence from recent (pre-)clinical studies that other issues may also be at stake. For instance, the choice of stem cells to be used and its precise mechanism of action, the need/possibility for concurrent tissue regeneration in case of irreversible tissue loss, the differentiation degree and specific vascular identity of the transplanted cells and the long-term survival of engrafted cells in the absence of a normal supportive tissue environment, should be well considered. Here, rather than presenting a comprehensive and extensive overview on the current literature on stem/progenitor cells and revascularization, we highlight some of the outstanding issues emerging from the recent (pre-)clinical literature that may co-determine the successful application of stem cells in a wide range of PVD patients in the future.

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“…These promising results from experimental studies promoted the initiation of clinical trials. One of the first was the Therapeutic Angiogenesis by Cell Transplantation (TACT) study by Tateishi-Yuyama et al (127), including a pilot study followed by a controlled and randomized study. In the pilot trial, 25 patients with unilateral ischemia of the leg were injected with BM-MNCs into the gastrocnemius of the ischemic limb and with saline into the less ischemic limb.…”

Section: Peripheral Arterial Occlusive Diseasementioning

confidence: 99%