More than two years after approval, Vertex’s CRISPR-based sickle-cell treatment Casgevy has treated only about 60 patients worldwide, with specialty centers reporting a key bottleneck: insufficient collection of patient cells to manufacture individualized products. The rollout problem has surprised clinicians and threatens to slow wider uptake. Clinics cited logistics and collection challenges as limiting factors, including patient health at collection, center capacity and manufacturing yield. The shortage contrasts with expectations that approved gene-editing therapies would rapidly scale to treat eligible patients. The issue raises questions for manufacturers, payors and policy makers about how to convert regulatory approvals into accessible, scalable therapies—particularly for autologous cell-based, gene-editing products that rely on complex supply chains.