Cesca
Therapeutics, Inc. (NASDAQ: KOOL) describes itself as being “engaged in the
research, development, and commercialization of cell-based therapeutics for use
in regenerative medicine.” The company focuses on three markets: therapies,
medical and diagnostic devices, and cell manufacturing and banking services.
Most recently, the company’s CLIRST III trial was approved by the U.S Food and
Drug Administration (FDA).
The
CLIRST III trial is being undertaken to determine the safety and efficacy of
Cesca’s SurgWerks-CLI platform. This platform is for the treatment of people
with late-stage, no option or critical limb ischemia (CLI). The CLIRST III
clinical study “is a prospective, double-blinded, randomized,
placebo-controlled, multi-center, pivotal clinical study in which subjects are
evaluated for prevention of major limb amputation in the treatment of
non-reconstructable Rutherford Category 5 critical limb ischemia (CLI),”
according to a study sponsored by Cesca described on the ClinicalTrials.gov
website.
The
trial is expected to begin in late 2016 and is for patients between the ages of
40 and 85. Participating patients will have been told by their doctors that
amputation is the only option, or that they have Rutherford Stage 5 foot
ulcers, or ulcers on their feet that do not heal. Other issues that the
treatment could benefit include CLI or leg and foot pain while walking or at
rest. The patients taking part in the study will be randomized in three to one
ratios, with three receiving device treatments and one receiving a placebo
treatment.
Cesca’s
treatments and products do not stop at its Critical Limb Ischemia Rapid
Stemcell Treatment. The company also offers a range of products, including
Cellular Bioprocess Technologies such as The AutoXpress® Platform. In addition
to this, KOOL also has the MarrowXpress™ (MXP™) System, which defines new
processing standards for isolating and concentrating stem cells from bone
marrow aspirate. Other products include cord blood transfer and freezing bag
sets, as well as the BioArchive® System, which is the only 100 percent robotic
storage and retrieval system for cryopreserving stem cell samples.
For
more information, visit the company’s website at www.CescaTherapeutics.com
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