Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer

Recently, animal studies have demonstrated the efficacy of endothelial progenitor cell (EPC) therapy for diabetic wound healing. Based on these preclinical studies, we performed a prospective clinical trial phase I/IIa study of autologous G-CSF-mobilized peripheral blood (PB) CD34 + cell transplanta...

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Main Authors: Rica Tanaka M.D., Ph.D., Haruchika Masuda, Shunichi Kato, Kotaro Imagawa, Kazuo Kanabuchi, Chie Nakashioya, Fumiaki Yoshiba, Tsuyoshi Fukui, Rie Ito, Michiru Kobori, Mika Wada, Takayuki Asahara, Muneo Miyasaka
Format: Article
Language:English
Published: SAGE Publishing 2014-03-01
Series:Cell Transplantation
Online Access:https://doi.org/10.3727/096368912X658007
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author Rica Tanaka M.D., Ph.D.
Haruchika Masuda
Shunichi Kato
Kotaro Imagawa
Kazuo Kanabuchi
Chie Nakashioya
Fumiaki Yoshiba
Tsuyoshi Fukui
Rie Ito
Michiru Kobori
Mika Wada
Takayuki Asahara
Muneo Miyasaka
author_facet Rica Tanaka M.D., Ph.D.
Haruchika Masuda
Shunichi Kato
Kotaro Imagawa
Kazuo Kanabuchi
Chie Nakashioya
Fumiaki Yoshiba
Tsuyoshi Fukui
Rie Ito
Michiru Kobori
Mika Wada
Takayuki Asahara
Muneo Miyasaka
author_sort Rica Tanaka M.D., Ph.D.
collection DOAJ
description Recently, animal studies have demonstrated the efficacy of endothelial progenitor cell (EPC) therapy for diabetic wound healing. Based on these preclinical studies, we performed a prospective clinical trial phase I/IIa study of autologous G-CSF-mobilized peripheral blood (PB) CD34 + cell transplantation for nonhealing diabetic foot patients. Diabetic patients with nonhealing foot ulcers were treated with 2 × 10 7 cells of G-CSF-mobilized PB CD34 + cells as EPC-enriched population. Safety and efficacy (wound closure and vascular perfusion) were evaluated 12 weeks posttherapy and further followed for complete wound closure and recurrence. A total of five patients were enrolled. Although minor amputation and recurrence were seen in three out of five patients, no death, other serious adverse events, or major amputation was seen following transplantation. Complete wound closure was observed at an average of 18 weeks with increased vascular perfusion in all patients. The outcomes of this prospective clinical study indicate the safety and feasibility of CD34 + cell therapy in patients with diabetic nonhealing wounds.
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spelling doaj.art-54834e497cee40b9a357c2ee50f44c9f2022-12-22T02:41:44ZengSAGE PublishingCell Transplantation0963-68971555-38922014-03-012310.3727/096368912X658007Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing UlcerRica Tanaka M.D., Ph.D.0Haruchika Masuda1Shunichi Kato2Kotaro Imagawa3Kazuo Kanabuchi4Chie Nakashioya5Fumiaki Yoshiba6Tsuyoshi Fukui7Rie Ito8Michiru Kobori9Mika Wada10Takayuki Asahara11Muneo Miyasaka12Department of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Plastic and Reconstructive Surgery, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Cardiovascular Surgery, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Blood Transfusion Service, Cell Transplantation and Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Blood Transfusion Service, Cell Transplantation and Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Plastic and Reconstructive Surgery, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Regenerative Medicine, Tokai University School of Medicine, Isehara, Kanagawa, JapanDepartment of Plastic and Reconstructive Surgery, Tokai University School of Medicine, Isehara, Kanagawa, JapanRecently, animal studies have demonstrated the efficacy of endothelial progenitor cell (EPC) therapy for diabetic wound healing. Based on these preclinical studies, we performed a prospective clinical trial phase I/IIa study of autologous G-CSF-mobilized peripheral blood (PB) CD34 + cell transplantation for nonhealing diabetic foot patients. Diabetic patients with nonhealing foot ulcers were treated with 2 × 10 7 cells of G-CSF-mobilized PB CD34 + cells as EPC-enriched population. Safety and efficacy (wound closure and vascular perfusion) were evaluated 12 weeks posttherapy and further followed for complete wound closure and recurrence. A total of five patients were enrolled. Although minor amputation and recurrence were seen in three out of five patients, no death, other serious adverse events, or major amputation was seen following transplantation. Complete wound closure was observed at an average of 18 weeks with increased vascular perfusion in all patients. The outcomes of this prospective clinical study indicate the safety and feasibility of CD34 + cell therapy in patients with diabetic nonhealing wounds.https://doi.org/10.3727/096368912X658007
spellingShingle Rica Tanaka M.D., Ph.D.
Haruchika Masuda
Shunichi Kato
Kotaro Imagawa
Kazuo Kanabuchi
Chie Nakashioya
Fumiaki Yoshiba
Tsuyoshi Fukui
Rie Ito
Michiru Kobori
Mika Wada
Takayuki Asahara
Muneo Miyasaka
Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
Cell Transplantation
title Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
title_full Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
title_fullStr Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
title_full_unstemmed Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
title_short Autologous G-CSF-Mobilized Peripheral Blood CD34 Cell Therapy for Diabetic Patients with Chronic Nonhealing Ulcer
title_sort autologous g csf mobilized peripheral blood cd34 cell therapy for diabetic patients with chronic nonhealing ulcer
url https://doi.org/10.3727/096368912X658007
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