Urinary Incontinence Study Using the Celution(R) System Approved in Japan
Cytori Therapeutics, Inc.
Press Release Source: Cytori Therapeutics, Inc. On Wednesday May 25, 2011, 9:00 am EDT
SAN DIEGO, CA--(Marketwire - 05/25/11) - Cytori Therapeutics (NASDAQ:CYTX - News) has learned that the Japanese Ministry of Health, Labor and Welfare ("MHLW"), the Japanese health regulatory body, has approved Nagoya University's independent clinical study to assess the efficacy of adipose-derived stem and regenerative cells (ADRCs) in the treatment of stress urinary incontinence.
MHLW approval to proceed with the study reflects Cytori's open operating system model in which hospital-based Celution® Systems may be used by different specialties for their own clinical research. This allows potential applications beyond our core focus to be advanced by independent groups. The study may be used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world.
"This is an example of a translational medicine application that has evolved into an approved clinical study," said Marc Hedrick, President of Cytori. "Our intention is to leverage this data, should we see positive results, to work towards making this a standard of care for patients around the world."
This open label, non-randomized study will enroll up to 20 patients with mild incontinence, both females and males, at the Nagoya University Graduate School of Medicine and a potential second site. Each patient will receive an injection of Celution® derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent. Patients will be assessed for incontinence (via 24 hr. pad test), quality of life and sphincter function. The study will be led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine.
"We are enthusiastic that this Celution® based treatment could be effective across a broad spectrum of patients who suffer from stress urinary incontinence," said Dr. Gotoh.
Cytori Therapeutics, Inc.
Press Release Source: Cytori Therapeutics, Inc. On Wednesday May 25, 2011, 9:00 am EDT
SAN DIEGO, CA--(Marketwire - 05/25/11) - Cytori Therapeutics (NASDAQ:CYTX - News) has learned that the Japanese Ministry of Health, Labor and Welfare ("MHLW"), the Japanese health regulatory body, has approved Nagoya University's independent clinical study to assess the efficacy of adipose-derived stem and regenerative cells (ADRCs) in the treatment of stress urinary incontinence.
MHLW approval to proceed with the study reflects Cytori's open operating system model in which hospital-based Celution® Systems may be used by different specialties for their own clinical research. This allows potential applications beyond our core focus to be advanced by independent groups. The study may be used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world.
"This is an example of a translational medicine application that has evolved into an approved clinical study," said Marc Hedrick, President of Cytori. "Our intention is to leverage this data, should we see positive results, to work towards making this a standard of care for patients around the world."
This open label, non-randomized study will enroll up to 20 patients with mild incontinence, both females and males, at the Nagoya University Graduate School of Medicine and a potential second site. Each patient will receive an injection of Celution® derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent. Patients will be assessed for incontinence (via 24 hr. pad test), quality of life and sphincter function. The study will be led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine.
"We are enthusiastic that this Celution® based treatment could be effective across a broad spectrum of patients who suffer from stress urinary incontinence," said Dr. Gotoh.