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Turn from . . . On July 22nd Talaris Therapeutics announced that it had completed the first live 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 FCR001.
For some patients, organ transplants are sometimes the only way to save their lives.
However, 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 rejection.
unfortunately, long-term 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 serious infections.
FCR001 is an allogeneic cell therapy.
researchers obtain stem cells and promote cells from the donor blood that provides the transplanted organ, and use the manufacturing process to remove cells in which they may attack the host, freezing the enriched stem cells and the promoter cells for backup.
importthese cells into the patient after receiving an organ transplant to promote the production of donor immune cells and blood cells, as well as increase the host's immune tolerance.
the treatment has been granted the U.S. Food and Drug Administration's (FDA) eligibility for orphan medicine and advanced regenerative medicine (RMAT) certification. the
FREEDOM-1 trial is expected to recruit 120 adult patients who received LDKT.
so far, 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 Center. freedom-1, a phase 3 trial of
FCR001 in patients with live kidney transplants, is currently recruiting patients.
"We are 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 transplants.
"References: Talaris Therapeutics Alex First Patient Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney R. Retrieved 2020-07-23, from the attention of the "drug ming conde" WeChat public number.