Table 4.
The Number and Rate of Adverse Events. Six patients had blood collection to prepare autologous serum, arthroscopic examination, synovial harvest, and meniscus suture. One among six was discontinued because of cell proliferation problem, and finally, five patients had transplantation of synovial MSCs on the repaired meniscus. Safety had been monitored continually since patients approved for the clinical study until 24 weeks after synovial harvest.
| Site Event | Possibly related to cell trans- plantation (n = 5) | Non-related to cell trans- plantation (n = 6) | Total (n = 6) |
|---|---|---|---|
| Lower extreme | |||
| Knee pain after meniscal repair | 0 (0%) | 6 (100%) | 6 (100%) |
| Knee pain after additional suture of meniscus | 0 (0%) | 1 (17%) | 1 (17%) |
| Knee pain at surgical wounds for scope | 0 (0%) | 4 (67%) | 4 (67%) |
| Joint effusion (affected side) | 1 (20%) | 3 (50%) | 4 (67%) |
| Joint effusion (unaffected side) | 0 (0%) | 1 (17%) | 1 (17%) |
| Localized warmth of knee | 1 (20%) | 0 (0%) | 1 (17%) |
| Retear of sutured meniscus | 0 (0%) | 1 (17%) | 1 (17%) |
| Lower leg pain | 0 (0%) | 1 (17%) | 1 (17%) |
| Lower leg numbness | 0 (0%) | 1 (17%) | 1 (17%) |
| Foot numbness | 0 (0%) | 1 (17%) | 1 (17%) |
| Contact dermatitis of thigh | 0 (0%) | 1 (17%) | 1 (17%) |
| Contact dermatitis of knee | 0 (0%) | 1 (17%) | 1 (17%) |
| Head | |||
| Headache | 0 (0%) | 1 (17%) | 1 (17%) |
| Face | |||
| Eyelid pain | 0 (0%) | 1 (17%) | 1 (17%) |
| Gingivitis | 0 (0%) | 1 (17%) | 1 (17%) |
| Upper extreme | |||
| Contact dermatitis of forearm | 0 (0%) | 1 (17%) | 1 (17%) |
| Others | |||
| Cold symptom | 0 (0%) | 2 (33%) | 2 (33%) |
| Increase of CRP | 1 (20%) | 1 (17%) | 2 (33%) |
| Increase of AST/ALT | 0 (0%) | 1 (17%) | 1 (17%) |
| Increase of LDH | 0 (0%) | 1 (17%) | 1 (17%) |
| Blood pressure increase | 0 (0%) | 1 (17%) | 1 (17%) |
| Blood pressure decrease after blood collection |
0 (0%) | 1 (17%) | 1 (17%) |