We have recently developed a novel cell-based therapy consisting of autologous adult Regenerative Macrophages (REMaST®) for nervous tissue regeneration. Strong preclinical evidence has shown the ...effect of REMaST® on nerve growth and spinal cord injury (SCI) healing. Multiple administrations of REMaST®, starting from the subacute phase following severe (complete) compressive-contusive SCI, improved motor recovery and rewired the SCI hostile microenvironment, reducing the fibrotic scar, increasing vasculature and tissue oxygenation and dampening the chronic inflammation.
We now developed the GMP protocol to generate human REMaST® for clinical use. In this context, we developed quality controls (QCs) to define REMaST® quality attributes characterizing the safety (proliferation, genomic alteration), identity (gene and protein expression), and potency of the drug substance. Based on the major mechanisms of action observed in preclinical studies, we developed ad hoc potency/efficacy QCs to assess the neuroprotective (neurite outgrowth, neural cell survival in condition of oxygen and glucose deprivation), chemotactic (SDF-1), and immunomodulatory properties (skewing of M1 polarization).
We are further optimizing human REMaST® production using a close loop system enabling robust large-scale manufacturing of the drug product for clinical use.
