Table 3.
Published clinical trials with BM-MNC therapy in stroke patients.
| Author | Cell population | Number of patients treated (controls) |
Design | Route | Cell dose | Time window | Follow-up (months) | Adverse events |
|---|---|---|---|---|---|---|---|---|
| Suárez-Monteagudo et al. [14] | Autologous | 5 (0) | Open-label phase I | Intraparenchymal | 1.4–5.5 × 107 | 1–10 years | 12 | Headache, drowsiness, nausea, fever |
| Savitz et al. [11] | Autologous | 10 (0) | Open-label phase I | Intravenous | 7–10 × 106/kg | 24–72 hours | 6 | None study-related reported |
| Friedrich et al. [15] | Autologous | 20 (0) | Open-label phase I | Intra-arterial | 2.2 × 107 | 3–7 days | 6 | None study-related reported |
| Moniche et al. [7] | Autologous | 10 (10) | Observer-blinded phase I/II | Intra-arterial | 16 × 107 | 5–9 days | 6 | Seizures (2 of 10) |
| Prasad et al. [16] | Autologous | 11 (0) | Open-label phase I | Intravenous | 0.2–18 × 107 | 7–30 days | 6 | One reinfarction |
| Li et al. [17] | Autologous | 60 (40) | Observer-blinded phase I/II (hemorrhagic stroke) | Intraparenchymal | 0.2–2 × 107 | 5–7 days | 6 | Fever, one unspecified pulmonary tumor |
| Barbosa da Fonseca et al. [18], Battistella et al. [8], Rosado-de-Castro et al. [9] | Autologous | 12 (0) | Open-label phase I | Intravenous (n = 5), intra-arterial (n = 7) | 10–50 × 107 | 19–89 days | 6 | Seizures (7 of 12) |
| Prasad et al. [10] | Autologous | 85 (35) | Blinded randomized phase II | Intravenous | 28 × 107 | 18.5 days | 12 | None reported |
| Sharma et al. [19] | Autologous | 24 (0) | Open-label phase I/II (ischemic and hemorrhagic stroke) | Intrathecal | 1 × 106/kg | 40 months | 30 | None reported |
| Taguchi et al. [20] | Autologous | 12 (0) | Open-label phase I/II | Intravenous | 29 × 107 | 7–10 days | 6 | One recurrent stroke |