Talaris is committed to developing single-dose cell therapies that have the potential to free organ transplant recipients of the burdens and toxicities of lifelong immunosuppression, without rejecting their transplant organs; and to restore self-tolerance in individuals with severe autoimmune diseases. To accomplish this, we collaborate with many researchers, individuals living with kidney or autoimmune disease and their family members and caregivers, patient groups, and physicians, and we work closely with regulatory agencies.
Clinical trials serve a vital role in development of new therapeutic options. They are carefully regulated, monitored and conducted in specific populations to assess safety and efficacy.
Currently, access to Talaris investigational therapies is only possible through participation in clinical trials. Completing the necessary clinical trials and obtaining the data needed for review and approval by regulatory agencies is the fastest way towards making Talaris’ cell therapies potentially available to the greatest number of individuals in the future.
Talaris bases its position on Patient Early Access on these key considerations:
Whether based on available safety and efficacy data, sufficient evidence is established that the potential benefits to the patient(s) outweighs the potential risks.
Whether there is adequate capacity to collect and process the investigational cell therapy to complete the ongoing and planned clinical trials.
Whether it will compromise or delay ongoing clinical trials or future access for the broader community.
If you have additional questions about the FREEDOM-1 Study, please speak with your physician or fill out the contact form at the following link: https://freedom1study.com/contact/
As more information and clinical data become available, Talaris may revise this policy. If you would like to receive regular updates about Talaris please email firstname.lastname@example.org