Safety monitoring
NRS, pain
Safety and tolerability were assessed using the numerical rating scale for pain (The NRS with scores from 0 to 10 was used for its ease of application and validity in assessing acute and change in pain over time, with 0 and 10 representing “no pain” and “worst pain imaginable,” respectively. The minimally clinically important differences (MCIDs) for moderate pain (NRS 4–7) and severe pain (NRS 8–10) are 1.3 and 1.8, respectively, but there is no MCID for mild pain (NRS 1–3) (Semi-structured qualitative interviews were conducted just prior to and during the infusion process and repeated at 2 hours and 7 days post-infusion to better understand the SCIP experience. Interviews were recorded, transcribed verbatim, and analyzed using thematic analysis. The qualitative assessment of the volunteer experience of SCIP has been reported separately (We used a modified Skindex-16 questionnaire (