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

Abstract

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.

Efficiency of stem cell based therapy in the treatment of diabetic foot ulcer: a meta-analysis

“…However even numerous basic experiments have focus on the subject but unfortunately only a little of then come in to clinical practice, and even lesser became a standard clinical care. Several clinical trials [14][15][16] have evaluated the efficacy of stem cell treatment, although these trials were conducted on small sample sizes. Therefore, a systematic review was conducted in order to evaluate the effectiveness of stem cell-based therapy in the treatment of diabetic foot ulcers.…”

Vasculogenesis and Its Cellular Therapeutic Applications

“…Furthermore, a 3-year, followup assessment showed significantly lowered amputation rates [Matoba et al, 2008]. On the other hand, clinical therapeutic application of autologous G-CSF-induced PB-derived CD34-positive cells in diabetic patients revealed improvement in wound healing and vascular perfusion (a complete wound closure within 18 weeks of treatment and a decrease in major amputation rates among patients with nonhealing diabetic wounds) [Tanaka et al, 2014].…”

“…In order to increase the number of circulating CD34-positive cells in PB, some authors have used previously described mediators such as G-CSF to mobilize the cells from the BM before their application in cell therapy [Tanaka et al, 2014].…”

Basics of Adult Stem Cells, Mesenchymal and Hematopoietic Stem Cells for Future Clinical Application

“…We have previously reported the efficacy of G-CSF mobilized peripheral blood CD34 positive cell therapy for diabetic non healing wounds 20) . To the best of our knowledge, our study is the first clinical trial of transplantation of autologous and purified CD34 positive cells in patients with chronic non healing diabetic wounds.…”