Cytori
Therapeutics (NASDAQ:CYTX) has received Investigational Device
Exemption (IDE) approval from the FDA to begin a prospective clinical
trial to evaluate the safety and feasibility of Cytori Cell Therapy as a
potential treatment for hamstring injuries. The trial, referred to as
RECOVER, will begin as a ten-patient, open label study in 2014.
Following a 90-day assessment of the first ten patients, Cytori is
approved by the FDA to expand RECOVER to a multi-dose, multi-center,
double-blind, placebo-controlled trial. Cytori Cell Therapy is derived
from the Company’s Celution® System, which enables access to a patient’s
own adipose-derived regenerative cells (ADRCs) at the point-of-care.
RECOVER will evaluate Cytori Cell Therapy in patients with Grade II
tears of the hamstring muscle. RECOVER will initially enroll ten
patients in the United States. The first ten patients will be given one
of two doses of Cytori Cell Therapy in an open-label manner, with the
first five patients receiving the lower dose and the second five
patients receiving the higher dose. Once the safety and feasibility of
administering Cytori Cell Therapy has been confirmed in the first ten
patients (Part A), Cytori has the option to expand RECOVER to include an
additional 60-patients in the multi-center, double-blind,
placebo-controlled phase of the trial (Part B). The 60 patients would be
divided into three groups of 20 patients. Patients in a given group will
receive a lower dose, a higher dose or placebo. The study would assess
safety and tolerability and evaluate the effect of the cells on how fast
the muscle tear heals (ultrasound and MRI), muscle strength, muscle
function and pain. The timeline to complete the first phase of the study
will be provided once the trial is initiated and Cytori is able to
forecast enrollment.
“We have been studying ADRCs in acute and chronic muscle injuries in the
heart for more than a decade and Cytori Cell Therapy is thought to play
a role in improving perfusion and reducing inflammation in damaged
cardiac muscle,” said Christopher J. Calhoun, Chief Executive Officer of
Cytori. “Similarly, we believe ADRCs could support healing in injured
skeletal muscle such as that of a hamstring injury. Initially, RECOVER
involves a minimal, incremental investment for the first ten patients.
If successful, RECOVER may provide an accelerated path to market in the
U.S. targeting the millions of recreational and professional sports
injuries that occur each year.”
Cytori is building a cell therapy sports medicine business. In the U.S.,
the Company is pursuing a clinical development strategy initially with
the RECOVER trial. Internationally, the Company is in the process of
initiating two multi-center registries for related indications in
countries where the Celution® System is available for commercial use.
The ACHILLES Registry will collect data from patients with muscle and
ligament injuries treated with Cytori Cell Therapy and the RELIEVE
Registry will collect data from patients with osteoarthritis. Both
registries will collect patient data and may support future regulatory
and reimbursement efforts.
About Hamstring Injury
Hamstring injuries are a persistent problem among elite and amateur
athletes given the high incidence and recurrence rates, as well as the
lengthy recovery time. According to the Journal
of Orthopaedic & Sports Physical Therapy, nearly one third of
hamstring injuries recur within the first year following a return to
sport, with subsequent injuries often being more severe than the
original.
About Cytori Cell Therapy and ADRCs
Cytori Cell Therapy is a proprietary formulation of a patient’s own
regenerative cells derived from their own adipose (fat) tissue that is
delivered in the same surgical procedure using the Company’s Celution®
System. Adipose tissue is the richest source of stem and regenerative
cells in the body. This mixed population of cells, collectively referred
to as ADRCs, is accessible at the point-of-care through the Celution®
System for use in the same patient, creating new treatment opportunities
for currently unmet medical needs. ADRCs collectively contribute to the
healing process via cell-to-cell signaling, supporting improved blood
flow and regulation of the inflammatory response.
About Cytori
Cytori Therapeutics is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular
disease and other medical conditions. Our scientific data suggest ADRCs
improve blood flow, moderate the inflammatory 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
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding future
events and expectations, including but not limited to our belief that
Cytori Cell Therapy could support healing in injured skeletal muscles,
the potential for RECOVER trial data to accelerate market access and the
potential impact of registry data on future regulatory or reimbursement
efforts. These forward looking statements involve risks and
uncertainties, including the Company’s ability to manage a multi-center
clinical trial, regulatory uncertainties, the performance of our
products in skeletal muscles, dependence on third party performance, as
well as other factors which may be beyond the Company’s control. For
additional disclosure regarding these and other risks faced by Cytori
Therapeutics, we refer the reader to carefully review the section titled
"Risk Factors" in Cytori's filings with the SEC, including its annual
report on Form 10-K and subsequent quarterly reports on Form 10-Q.
Cytori assumes no responsibility to update any forward-looking
statements contained in this press release to reflect events, trends or
circumstances after the date of this press release.
Copyright Business Wire 2014