Investigator-Sponsored Cell Therapy Clinical Study for Scleroderma Initiated in France

  Investigator-Sponsored Cell Therapy Clinical Study for Scleroderma Initiated
  in France

Business Wire

SAN DIEGO -- October 23, 2012

Cytori Therapeutics (NASDAQ: CYTX) today announced  that an
investigator-sponsored and funded clinical study evaluating Cytori’s cell
therapy as a potential treatment for limited and diffuse cutaneous systemic
sclerosis (scleroderma) has been approved to begin in France by the National
Agency for the Safety of Medicines and Health Products (ANSM, formerly
AFSSAPS). The study will be conducted by Professor Guy Magalon, M.D., Chief of
the Division of Plastic Surgery and Professor of Universities, at Hộpital de
la Conception, AP-HM Marseille, France, Professor Brigitte Granel, M.D.,
Department of Internal Medicine of Hospital Nord and Professor of
Universities,  and Professor Florence Sabatier, M.D., Head of the Department
of Cell Therapy.

“We are interested in investigating Cytori’s cell therapy as a potential
treatment for scleroderma because earlier data suggest it can improve blood
flow and minimize the immune response,” said Professor Magalon. “Based on
these properties, the treatment has the potential to reverse the ischemic
effects, where there is tightening of the arteries in the affected areas, and
counter the autoimmune reaction. While this research is in its early stages,
if we begin to observe encouraging efficacy, we intend to expand the trial to
include more hospitals and patients.”

Per the study protocol, 13 patients will receive an injection of their own
adipose-derived stem and regenerative cells (ADRCs) into the affected areas of
their fingers. ADRCs will be processed using Cytori’s automated Celution®
System so that their own cells may be redelivered immediately. The primary
endpoints are safety and the improvement in function of the hands, as measured
by the Cochin hand functional scale at six months. Secondary endpoints include
severity of pain visual analog scale, Systemic Sclerosis Health Assessment
Questionnaire, Rodnan score adapted to the hand, HAMIS test, and severity of
the Raynaud’s syndrome. The first patient in the study is expected to be
treated in November 2012.

Scleroderma is a rare autoimmune disorder that results in an overproduction of
collagen in the skin and vital organs. It ranges from mild to severe, is
typically detected between the ages of 40 and 50, and it affects women four
times more frequently than men. It is classified as localized or systemic. Two
forms of systemic sclerosis include limited cutaneous and diffuse cutaneous,
depending on the extent of skin fibrosis. In both subgroups, skin fibrosis
affects the hands and leads to disability. Combined prevalence for limited and
diffuse cutaneous systemic scleroderma in the G6 European countries is
approximately 42,000 people. It is classified as an orphan disease by
Orphanet, a European consortium on rare diseases.

The study is being organized by a multidisciplinary team of researchers at
Hộpital de le Conception. The researchers include Julie Veran, Cell
Manufacturing Manager, Laurent Giraudo, Laboratory Chief Assistant, and
Laurent Arnaud, Cell Characterization responsible, of the Cell Therapy
Department. In addition, Aurelie Daumas, Chief Clinician Assistant from the
Department of Internal Medicine, and Pierre Nguyen, M.D., Chief Clinician
Assistant from the Department of Plastic & Reconstructive Surgery, will
support implementation of the study. Per the request of the ANSM, the
Department of Cell Therapy had previously validated the cell characterization,
viability and reproducibility of the ADRCs processed by the Celution® System.

About Cytori Therapeutics

Cytori Therapeutics, Inc. is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and
repair soft tissue defects. Our scientific data suggest ADRCs improve blood
flow, moderate the immune response and keep tissue at risk of dying alive. As
a result, we believe these cells can be applied across multiple "ischemic"
conditions. These therapies are made available to the physician and patient at
the point-of-care by Cytori's proprietary technologies and products, including
the Celution® System product family. www.cytori.com

Contact:

Cytori Therapeutics
Investors
Tom Baker, +1-858-875-5258
tbaker@cytori.com
or
Media
Megan McCormick, +1-858-875-5279
mmccormick@cytori.com