Table 2.
Safety (adverse events).
| Pts | No of tx | Route of administration | Intervals (months) | Adverse events | Severity | Outcome |
|---|---|---|---|---|---|---|
| 001 | 3 | 1—IV+IT 2—IV+IT 3—IV+IT |
0 6 12 |
1—none 2—none 3—none |
||
| 002 | 3 | 1—IV+IT 2—IV+IT 3—IV+IT |
0 12 24 |
1—headache, fever 2—headache 3—none |
1—mild 2—moderate | 1—resolved, 24 h 2—resolved, 3 days |
| 003 | 4 | 1—IV+IT 2—IV+IT 3—IV 4—IV |
0 12 24 36 |
1—fever, headache, general weakness 2—headache, general weakness 3—none 4—none |
1—mild 2—mild |
1—resolved, 3 days 2—resolved, 3 days |
| 004 | 8 | 1—IV+IT 2—IV+IT 3—IV+IT 4—IV+IT 5—IV+IT 6—IV+IT 7—IV 8—IV+IT |
0 6 12 18 24 30 36 42 |
1—headache, back pain 2—none 3—headache 4—back pain 5—none 6—none 7—none 8—headache |
1—moderate 3—mild 4—mild 8—mild |
1—resolved, 2 days 3—resolved, 24 h 4—resolved, 3 days 8—resolved 2 days |
| 005 | 8 | 1—IV + IT 2—IV 3—IV 4—IV 5—IV 6—IV 7—IV 8—IV |
0 6 12 18 24 30 36 42 |
1—none 2—none 3—none 4—none 5—none 6—none 7—none 8—none |
||
| 006 | 6 | 1—IV + IT 2—IV + IT 3—IV + IT 4—IV 5—IV + IT 6—IV + IT |
0 6 12 18 24 36 |
1—neck rigidity, headache, back pain, leukocytosis 2—headache, back pain 3—none 4—none 5—headache 6—headache |
1—severe 2—moderate 5—mild 6—mild |
1—resolved, 3 days 2—resolved, 4 days 5—resolved 24 h 6—resolved, 24 h |
| 007 | 6 | 1—IV + IT 2—IV 3—IV 4—IV 5—IV 6—IV + IT |
0 12 18 24 36 42 |
1—fever 2—none 3—none 4—none 5—none 6—headache |
1—moderate 6—mild |
1—resolved 24 h 6—resolved 24 h |
| 008 | 3 | 1—IV + IT 2—IV 3—IV |
0 12 24 |
1—none 2—none 3—none |
||
| 009 | 4 | 1—IV + IT 2—IV + IT 3—IV + IT 4—IT |
0 6 18 24 |
1—headache 2—fever, headache 3—none 4—none |
1—mild 2—moderate | 1—resolved 24 h 2—resolved 24 h |
| 010 | 3 | 1—IV + IT 2—IV 3—IV |
0 12 24 |
1—headache 2—none 3—none |
1—mild | 1—resolved 24 h |
| 011 | 2 | 1—IV + IT 2—IV |
0 12 |
1—none 2—none |
||
| 012 | 5 | 1—IV + IT 2—IV + IT 3—IV + IT 4—IV + IT 5—IV + IT |
0 6 18 30 42 |
1—none 2—fever 3—none 4—headache 5—none |
2—mild 4—mild |
2—resolved 24 h 4—resolved 3 days |
| 013 | 5 | 1—IV + IT 2—IV + IT 3—IV + IT 4—IV + IT 5—IT |
0 6 12 24 36 |
1—urinary retention, fever, headache 2—none 3—none 4—none 5—none |
1—moderate | 1—resolved, 24 h |
| 014 | 2 | 1—IV + IT 2—IV |
0 12 |
1—none 2—none |
||
| 015 | 3 | 1—IV + IT 2—IV + IT 3—IV + IT |
0 12 24 |
1—none 2—headache 3—none |
2—mild |
2—resolved 24 h |
| 016 | 3 | 1—IV + IT 2—IV + IT 3—IV |
0 12 24 |
1—none 2—none 3—none |
||
| 017 | 2 | 1—IV + IT 2—IV + IT |
0 6 |
1—fever 2—headache |
1—mild 2—mild |
1—resolved 24 h 2—resolved 24 h |
| 018 | 2 | 1—IV + IT 2—IV |
0 6 |
1—none 2—none |
||
| 019 | 2 | 1—IV + IT 2—IT |
0 6 |
1—none 2—none |
||
| 020 | 6 | 1—IV + IT 2—IV + IT 3—IV 4—IV + IT 5—IV + IT 6—IV + IT |
0 6 18 24 36 42 |
1—none 2—back pain 3—none 4—headache, fever 5—none 6—headache |
2—mild 4—mild 6—mild |
2—resolved, 3 days 4—resolved 24 h 6—resolved 24 h |
| 021 | 3 | 1—IV + IT 2—IV + IT 3—IV + IT |
0 12 24 |
1—none 2—none 3—none |
||
| 022 | 2 | 1—IV + IT 2—IV + IT |
0 6 |
1—none 2—none |
||
| 023 | 2 | 1—IV + IT 2—IV + IT |
0 12 |
1—back pain 2—back pain, sciatic pain |
1—mild 2—moderate |
1—resolved, 3 days 2—resolved 7 days |
| 024 | 2 | 1—IV + IT 2—IV |
0 6 |
1—none 2—none |
||
| Total: 89 |
IV = 86 injections IT = 64 injections IT + IV: 61 |
41 adverse events |
1 severe, 13 of moderate severity, others: mild |
All resolved between 1 and 7 days |
Tx = treatments with MSC; Pts = patients.