Cytori Therapeutics has announcedthat a 40-patient, multicentre investigator-sponsored and funded clinical study in Japan using the Celution System has been approved under the Ministry of Health, Labor and Welfare (MHLW) Guidelines on Clinical Research Using Human Stem Cells.
The study will investigate the use of patients’ own adipose-derived stem and regenerative cells (ADRCs) processed by the Celution System for peripheral artery disease or arteriosclerosis obliterans. The principal investigator will be Toyoaki Murohara, professor and chairman, Department of Cardiology at the primary trial centre, Nagoya University Graduate School of Medicine. The trial will include two additional Japanese sites.
“It has been reported by many researchers domestically (Japan) and overseas that transplantation of ADRCs stimulates vascularisation of an ischaemic area,” said Murohara. “Specifically, positive clinical results were reported with regards to the treatment for ischaemic heart failure in Europe using ADRCs. Although Japan has lagged far behind in this field, I believe that approval by MHLW under the new clinical research guidelines to study ADRCs for limb ischaemia is a big step for medical care of vascularisation therapy in Japan.”
This multicentre, single arm study will enrol up to 40 patients with peripheral artery disease, Burger’s disease, or with severe limb ischaemia caused by connective tissue disease. Each patient will receive an injection of their own ADRCs into the skeletal muscle at the affected area on the limb. Patients will undergo follow-up examinations at one week and at one, three and six months with primary endpoints of safety and limb salvage rate as compared to conventional treatment.