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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