Gamida Cell has signed a collaboration agreement with Biologics Delivery Systems Group, Cordis.
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Under the terms of the agreement, Biologics Delivery Systems will supply catheters for the upcoming Phase I/II clinical trial of Gamida Cell’s CardioCure product for the treatment of post-myocardial infarction (MI) patients. CardioCure is a proprietary ex-vivo expanded autologous bone marrow product.
The randomized, controlled multi-center Phase I/II clinical trial, due to start in the fourth quarter of 2008 in Israel, will evaluate the safety and efficacy of Gamida Cell’s CardioCure in 48 post-MI patients. CardioCure will be injected directly into the myocardium using the latest generation of Biologics Delivery Systems’s Noga cardiac navigation system and MyoStar injection catheter.
Pre-clinical results demonstrate that CardioCure may offer a better therapeutic alternative to existing treatments. The data indicate that it may prevent or lessen some of the damage caused to the heart muscle as a result of a heart attack.
Ran Kornowski, principal investigator in the Gamida Cell CardioCure clinical study, said: “The Noga XP cardiac navigation system is a highly sophisticated and accurate electro-guided methodology, which creates precise, three-dimensional images of the heart. This will enable us to identify damaged myocardial tissue and accurately deliver the CardioCure injections into the relevant area in order to assist with functional restoration of the damaged heart.”
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