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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