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TOPIC: Nagoya PAD clinic from 2012

Nagoya PAD clinic from 2012 10 Feb 2016 12:48 #6285

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As Hedrick mentioned at the end of the Convene presentation-

He does not have the data yet, but it is done and they- the data- should come available- I believe that one should be a slam dunk just like scleroderma and also OA. With a 50% reduction in pain in placebo and treated patients doing better than that, there is no reason to doubt efficacy in my humble opinion. :yawn:

Multicenter Investigator-Sponsored Cell Therapy Study for Peripheral Artery Disease Approved in Japan
09/13/2012

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) today announced that a 40-patient, multi-center 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 (PAD) or arteriosclerosis obliterans (AO). PAD or AO are common circulatory problems in which narrowed arteries reduce blood flow to the limbs. The principal investigator will be Toyoaki Murohara, M.D., Ph.D., Professor and Chairman, Department of Cardiology at the primary trial center, 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 vascularization of an ischemic area,” said Dr. Murohara. “Specifically, positive clinical results were reported with regards to the treatment for ischemic 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 ischemia is a big step for medical care of vascularization therapy in Japan.”

This multi-center, single arm study will enroll up to 40 patients with peripheral artery disease, Burger’s disease, or with severe limb ischemia 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.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Nagoya PAD clinic from 2012 11 Feb 2016 04:14 #6306

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Even if Cytori does not have data (assuming that is the truth :whistle: ) , one can reasonably assume that this application is relatively close to generating revenues through the "conditional approval" process as per the new regenerative law.... :grin:

40 patients treated- all being Japanese- would definitely fall within the requirements of the agency and might be the first success Harris can write on his banner and relate to the "great opportunities the Japanese market offer", which Hedrick was talking about at the last CC.

And John and I have reminded this board about the study also several times... :grin:

And the only ones who has NOT reminded investors of its existence was Cytori and Marc Hedrick :cool:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Nagoya PAD clinic from 2012 11 Feb 2016 06:45 #6309

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Positive news could come at any time from anywhere. We have a large number of trials from a variety of countries that confirm the efficacy of the Celution treatment for PAD. Validation by the Japanese authorities would be substantial, particularly if followed by a partnership deal for the indication in Japan for cash.

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