Table 3.
Serious Treatment-Emergent Adverse Events
| MedDRA System Organ Class Preferred Term |
Number (%) of Subjects |
|---|---|
| Cardiac disorders | 1 (3) |
| Cardiac failure1 | 1 (3) |
| General disorders and administration site conditions | 1 (3) |
| Malaise | 1 (3) |
| Infections and infestations | 2 (6) |
| Cellulitis2 | 1 (3) |
| Wound infection3 | 1 (3) |
| Musculoskeletal and connective tissue disorders | 1 (3) |
| Foot deformity | 1 (3) |
| Renal and urinary disorders | 1 (3) |
| Renal amyloidosis | 1 (3) |
| Respiratory, thoracic, and mediastinal disorders | 1 (3) |
| Pulmonary embolism1 | 1 (3) |
| Skin and subcutaneous tissue disorders | 2 (6) |
| Skin ulcer4,5 | 2 (6) |
| Any event | 7 (23) |
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.
Serious treatment-emergent adverse events are reported for the safety analysis set (n = 31). None of these events was related to the study treatment.
Event had a fatal outcome.
Moderate cellulitis originating from a superinfected nontarget (not cell-treated) ulcer, starting 9 months after the first and only cell application.
Severe postoperative wound infection after toe amputation due to foot deformation caused by rheumatoid arthritis, starting 11 months after the first and only cell application.
Worsening of the CVU, starting 3 months after the second cell application, required hospitalization owing to poor social situation of the subject.
Worsening of a skin ulcer at the contralateral foot, starting 4 weeks after the first cell application.