Study design
This phase 1/2, randomized, controlled clinical trial was designed to evaluate the safety and efficacy of intranasal delivery of NSCs loaded by degradable patches. According to the principle of continuous enrollment, we randomly assigned all 25 patients who met the enrollment conditions from January 2018 to March 2019, including 15 patients in the treatment group (receiving NSCs transplantation three times and rehabilitation therapy; Patients 1–15) and 10 patients in the control group (receiving rehabilitation therapy only; Patients 16–25). This study was registered with ClinicalTrials.gov (NCT03005249) and the Medical Research Registration Information System (CMR-20161129–1003). And it was approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University. The reference number of the ethics approval was LCKY2016-60.