This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.
What is FCR001:
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor’s CD34+ cells, facilitating cells, and αβ T cells. This therapy induces or restores patients’ immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.
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With the growing stem cell therapy pipeline, do we have enough manufacturing capacity:
Given complex manufacturing protocols, and high development costs, stem cell therapy developers are increasingly becoming dependent on contract service providers to leverage long term expertise and optimize operating expenses.
Who are the CMOs that can manufacture stem cell therapies: More than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing for various types of stem cell therapies.
With increasing application in regenerative medicine and other neuro-related disorders, stem cell therapies have gained traction in the last few years. In fact, more than 500 interventional stem cell-related clinical studies have been registered in the last five years.
Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers.