Cytori Cell Therapy™ Clinical Trial Results in Crohn’s Disease
January 31 2019 - 8:30AM
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announces the
publication of results from a pilot investigator-initiated clinical
trial of Cytori Cell Therapy™ for the treatment of refractory
perianal fistula in patients with Crohn’s Disease. These findings
were published online this month in the journal Gastroenterology1,
a publication of the American Gastroenterological Association.
Highlighted results from this study:
- 10 patients were treated with a single administration of Cytori
Cell Therapy™. No significant safety concerns were noted as part of
the therapy.
- 80% of patients exhibited a clinical response at 48 weeks; 60%
of patients were deemed in combined remission with no evidence of
leakage by clinical examination or MRI.
- 76% of treated external fistula openings showed complete
re-epithelialization or an absence of drainage at week 48
- >50% decrease in mean Perianal Crohn’s Disease Activity
Index (PDAI) 2 at 48 weeks (7.3 points at baseline to 3.4 points at
48 weeks). Mean PDAI score at 12 and 48 weeks after treatment (3.8
points and 3.4 points respectively) was below the threshold score
of 4 that indicates active disease, requiring medical or surgical
treatment.
The treatment approach involved a single administration of an
average dose of 23 M freshly prepared autologous adipose-derived
regenerative cells (ADRCs) into the fistulous tract in combination
with an autologous adipose micrograft. Cytori Cell Therapy™ was
prepared using Cytori’s Celution® 800/CRS System, similar to the
product that was recently approved as a Class III medical device in
Japan.
Crohn’s Disease (CD) is a rare, chronic idiopathic inflammatory
bowel disease condition with no cure that is characterized by
flares and remission across the entire gastrointestinal tract from
the mouth to the anus. Perianal fistulas are a common in CD
(26% of patients within 20 years of CD diagnosis) and typically
complex (70-80% of perianal fistulas). These fistulas cause
pain, depression, a decreased quality of life, and an increased
risk of anal epithelia carcinoma. Management of these
fistulas has improved over the last 20 years, but even with the
latest combined medical and surgical approaches, healing rates have
only approached 50%.
CD can affect people of all ages, though onset is most common in
late adolescence and early adulthood, and has a prevalence of
up to 0.2% (201 existing cases per 100,000 population) and
incidence of 0.015% (14.6 new cases per 100,000 population)
according to the CDC.
The study was conducted by a team of investigators from the
Departments of Gastroenterology, Digestive Surgery, Plastic
Surgery, and Cell Therapy of the Assistance Publique Hôpitaux de
Marseille (APHM), Aix Marseille University, France. Cytori
Cell Therapy has also been evaluated in clinical studies at this
Institution for scleroderma and vocal cord scarring. Data
from these studies are expected in 2019.
Cytori’s Cell Therapy products may have broad applicability
across a range of diseases and conditions. It has been
evaluated in both pre-clinical and clinical research studies and
cited in over 65 publications. References to these studies
can be found on Cytori’s website.
1"Long-term safety and efficacy of local microinjection
combining autologous microfat and adipose-derived stromal vascular
fraction for the treatment of refractory perianal fistula in
Crohn's disease” Serrero et al Gastroenterology. 2019 Jan 18.
pii: S0016-5085(19)30092-7
2The perianal disease activity index (PDAI) score includes the
evaluation of 5 elements: fistula discharge, pain and restriction
of activities, sexual activity restriction, type of perianal
disease, and degree of induration. A PDAI score >4 suggests
active fistula drainage or local inflammation, with an accuracy of
87%. This score has been validated in several clinical trials.
About Cytori Therapeutics, Inc.
Cytori is a therapeutics company developing regenerative and
oncologic therapies from its proprietary cell therapy and
nanoparticle platforms for a variety of medical conditions. Data
from preclinical studies and clinical trials suggest that Cytori
Cell Therapy™ acts principally by improving blood flow, modulating
the immune system, and facilitating wound repair. As a result,
Cytori Cell Therapy™ may provide benefits across multiple disease
states and can be made available to the physician and patient at
the point-of-care through Cytori’s proprietary technologies and
products. Cytori Nanomedicine™ is developing liposome encapsulated
therapies for regenerative medicine and oncologic indications. For
more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes forward-looking statements regarding
events, trends and business prospects, which may affect our future
operating results and financial position. Such statements,
including, without limitation, conduct of clinical trials involving
our technology, clinical performance, and product approvals, are
all subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. Some of these
risks and uncertainties include, but are not limited to, inherent
risk and uncertainty in the protection intellectual property
rights, regulatory uncertainties, risks in the conduct of clinical
trials, risks in the collection and results of clinical data, final
clinical outcomes, dependence on third party performance,
performance and acceptance of our products in the marketplace, as
well as other risks and uncertainties described under the heading
"Risk Factors" in Cytori's Securities and Exchange Commission
Filings on Form 10-K and Form 10-Q. We assume no responsibility to
update or revise any forward-looking statements to reflect events,
trends or circumstances after the date they are made.
Investor Contact:
Tiago GiraoCytori Therapeutics, Inc. 1-858-458-0900
ir@cytori.com
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