A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial

Table 5 Interim and final analyses

1st interim analyses	Early evaluation for safety and feasibility, when all 24 patients of phase I are randomized and tissue explants, implant procedures, and 6-week follow-up visits are completed.
2nd interim analyses	Final evaluation for surgical feasibility of the procedures, when all enrolled patients have completed the sequestrectomy and transplantation.
3rd interim analyses	Early evaluation for efficacy with patients who have completed the 12-month follow-up visit.
4th interim analyses	Primary evaluation for efficacy with all patients who have completed the 24-month follow-up visit.
Final analyses	When all patients have completed the scheduled 60-month follow-up visit.

ISSN: 1745-6215