Clinical Efficacy Of New Generation Vascular And Tissue Regenerative Cell (MNC-QQ) Therapy For Non-healing Ischemic Ulcer
Rica Tanaka, Taro Fukuta, Satoshi Fujimura, Kayo Arita, Rie Hirano, Hiroshi Mizuno.
Juntendo University School of Medicine, Tokyo, Japan.
BACKGROUND: Angiogenesis is an important factor in non-healing ishcemi ulcers. Recently, we have reported the novelty of serum free ex vivo expansion system called Quantity and Quality Culture System (QQc) using peripheral blood mononuclear cells (PbMNC) as non-invasive and effective vascular and tissue regenerative cell therapy. The objective of this study is to investigate the safety and efficacy of QQ cultured PbMNC (MNC-QQ therapy) on non-healing ischemic extremity wounds.
METHODS: 200ml of peripheral blood was drawn from patients with chronic (>3 months) ischemic extremity ulcers in an outpatient basis. Mononuclear cells were isolated and cultured in QQc for one week without passaging or media changes. Under local anesthesia, 2x107 cells were injected within 20 cm2 of the chronic wound and wound healing was monitored by photometrically. The adverse effects were evaluated. Wound closure, VAS scale, skin perfusion pressure (SPP), TcPo2, laser doppler, thermography and angiography were performed to evaluate efficacy post 2,4,8 and 12 weeks therapy.
RESULTS: A total of nine patients, ten limbs were enrolled. The age ranged from 64 to 74 years old. Eight males and one female. Seven patients had diabetes with renal failure and two with collagen disease as past medical history. Blood sugar levels were controlled for all patients, and HbA1C was below 8.0%. All of the wounds extended into bone or tendon and were located in the digits of the foot. All patients were ambulant without major amputation. There was no death, other serious adverse events, or major amputation seen within 12 weeks following transplantation. Increased vascular perfusion with decrease in VAS scale were seen in all patients. Interestingly, SPP significantly increase post therapy.
CONCLUSIONS: The outcomes of this prospective clinical study indicate the safety and feasibility of MNC-QQc cell therapy in patients with ischemic nonhealing wounds. This methodology will allow us to transplant highly vasculogenic peripheral blood stem cells from small amount of blood draw.
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