Results from the first study, "Ixmyelocel-T, an Expanded Multicellular Therapy, Contains a Unique Population of M2-Like Macrophages", show that ixmyelocel-T contains M2-like macrophages characterized by expression of multiple, well-known M2 macrophage markers, decreased secretion of pro-inflammatory cytokines after inflammatory stimuli, and efficient removal of apoptotic cells. The population of macrophages generated in ixmyelocel-T is believed to play a role in tissue repair and regeneration.
"Our data demonstrate that ixmyelocel-T therapy contains a unique population of M2-like macrophages characterized by secretion of anti-inflammatory cytokines and expression of M2 markers CD206 and CD163. In addition to being involved in efficient removal of apoptotic cells, they also show elevated expression of MerTK, which is essential in limiting tissue injury and promoting repair. These findings provide further indication that these cells may play a key role in the treatment of diseases where tissue remodeling and immunomodulation are components of successful clinical outcomes," said Dr.
In the second study, titled "Potential Beneficial Effects of Ixmyelocel-T in the Treatment of Atherosclerotic Diseases", ixmyelocel-T was treated with modified low-density lipoprotein (LDL) similar to that found in atherosclerotic plaques. The amounts of LDL uptake and expression of cytokines and key cholesterol transport genes were then measured in an attempt to mimic the pro-inflammatory environment in atherosclerotic lesions. The results of these analyses showed that ixmyelocel-T macrophages are able to influx modified cholesterol, remain anti-inflammatory in the face of lipid loading and inflammatory challenge, and display enhanced cholesterol efflux capabilities.
"This study indicates that the unique M2-like population of macrophages found in ixmyelocel-T is efficient at maintaining cholesterol homeostasis. As a result, ixmyelocel-T macrophages may exert highly beneficial effects and represent a potential new modality in the treatment of atherosclerotic disease," Dr. Bartel said.
Ixmyelocel-T is a patient-specific multicellular therapy expanded from a patient's own bone marrow. It is currently being evaluated in a Phase 2b clinical trial for treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The Phase 2a trial in DCM patients confirmed that ixmyelocel-T was well-tolerated and that efficacy observations were consistent with improved function of impaired myocardium. Health
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