Table 2.
Significant adverse events retrospectively collected at long-term follow-up of STEMS phase I study patients
| AEs Description | Patient’s ID and TC | Severity | Action taken | Outcome | Causal relationship to study procedure |
|---|---|---|---|---|---|
| MGUS IgG kappa at low risk of progression | #001, TC-1 | Grade1 | FU | Ongoing | Unlikely |
| Hypertransaminasemia | #004, TC-1 | Grade1 | FU | Spontaneously resolved | Unlikely |
| Post-traumatic tibial fracture | #007, TC-2 | Grade3* | Surgery | Resolved | Unlikely |
| Post-traumatic spinal and pelvic fracture | #010, TC-3 | Grade3* | Surgery | Resolved | Unlikely |
| Breast ductal carcinoma in situ | #013, TC-4 | Grade3 | Surgery and RT | Complete remission | Unlikely |
| Angiomyolipoma enlargement | #015, TC-4 | Grade3 | TAE | Volumetric reduction | Unlikely |
AEs: Adverse events; TC: treatment cohort (as reported in the online methods section, STEMS-patients were consecutively enrolled in 4 treatment cohorts (TCs), each receiving a single intrathecal administration of one of the four increasing treatment doses of hfNPCs (TC-A: 0.7 × 106, TC-B: 1.4 × 106, TC-C: 2.8 × 106 and TC-D: 5.7 × 106 ± 10% viable cells per kilogram of body weight); MGUS: Monoclonal gammopathy of undetermined significance; FU: Follow-up; RT: radiotherapy; TAE: transarterial Embolization
*Limiting self-care ADL