Innovative cell therapy FCR001 completed the first live kidney transplant in Phase 3 clinical lysa.
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Last Update: 2020-07-29
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Source: Internet
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Author: User
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On July 22, Talaris Therapeutics announced that it had completed the first active kidney transplant (LDKT) in a phase 3 clinical trial called FREEDOM-1 in cell therapy FCR001, which is designed to assess the safety and effectiveness of A single dose of FCR001For some patients, organ transplantation is sometimes the only way to save their livesHowever, even with an organ transplant, the body's immune rejection of transplanted organs can still pose significant challenges to the lives and health of these patients, many of whom have to take immunosuppressive drugs for life to avoid rejectionUnfortunately, prolonged suppression of a patient's immune system can have serious side effects that can lead to an increased risk of cardiovascular disease and cancer, as well as reduced resistance to severe infectionsFCR001 is an allogeneic cell therapyThe researchers obtained stem cells and cell-promoting cells from the donor blood that provided the transplanted organ, and used a manufacturing process to remove cells in which they might attack the host, freezing the enriched stem cells and the promoter cells for backupThese cells are fed into the patient after an organ transplant to promote the production of donor immune cells and blood cells, while improving the host's immune toleranceThis treatment has been granted the U.SFood and Drug Administration 's (FDA) Eligibility for Orphan Medicine and the Advanced Regenerative Medicine (RMAT) CertificationThe FREEDOM-1 trial is expected to recruit 120 adult patients who received LDKTTo date, the trial has been launched at several clinical centers across the United States, including Northwestern Memorial Hospital, Duke University Medical Center, and the University of Nebraska Medical CenterTHE PHASE 3 TRIAL FREEDOM-1 OF FCR001 IN PATIENTS WITH LIVE KIDNEY TRANSPLANTS IS CURRENTLY RECRUITING PATIENTS"We are very proud that Talaris started administering drugs in the FREEDOM-1 trial, and thank doctors and patients for their active participation in our efforts to promote the development of this potentially transformative treatment .We look forward to providing a future without chronic immunosuppression for patients with live kidney transplantsReferences: Talaris Therapeutics First Patient Patient Dosed Phase in 3 Clinical Trial of FCRR001 in Living Donor Kidney Donor TedRetrieved 2020-07-23, from
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