Table 3.
Clinical trials of MSCs in the treatment of patients with IS.
| Type of trial | Stroke type | Sample sizes | Cell type | Dose/single (S) or multiple (M) | Route | Time of adm. from stroke onset | Follow-up | Result | Reference |
|---|---|---|---|---|---|---|---|---|---|
| RCT | Acute IS | 30 | BM-MSCs/autologous | 5 × 107/M | IV | 4-5 weeks 7-9 weeks |
1 year | Significant improvement in BI. No significant difference in NIHSS and MRI scan | [200] |
| RCT | Acute IS | 85 | BM-MSCs/autologous | 5 × 107/M | IV | 5 weeks 7 weeks |
5 years | No significant side effects. Patients with mRS 0–3 significant increased | [201] |
| OL-PT | Chronic IS | 12 | BM-MSCs/autologous | 0.6–1.6 × 108/S | IV | 36–133 days | 1 year | No side effects. Decreasing of infarct volume by>20% at 1 week | [210] |
| OL-PT | Subacute IS | 11 | BM-MSCs/autologous | 85 × 106/S | IV | 7–30 days | 6 months | No side effects. Improvement in NIHSS, BI, and mRS | [211] |
| SB-CT | Acute IS | 20 | BM-MNCs/autologous | 1.59 × 108/S | IA | 5–9 days | 180 days | No side effects. No significant differences in neurological function | [212] |
| OL-PT | Chronic IS | 36 | BM-MSCs/allogeneic | 1.5 × 106/S | IV | >60 days | 12 months | No side effects. Significant improvement in BI and NIHSS | [213] |
| OL-PT | Chronic IS | 18 | SB623 cells/allogeneic | 2.5 × 106/S 5.0 × 106/S 10 × 106/S |
IC | >60 days | 24 months | All experienced at least 1 treatment-emergent adverse event. Significant improvements in NIHSS F-M and ESS | [205] |
| RCT | Subacute IS | 31 | BM-MNCs/autologous | 1.0 × 106/S 3.0 × 106/S |
IV | <2 weeks | 2 years | No significant improvements in NIHSS, BI, and mRs. Significant improvements in motor function | [202] |
| OL-PT | Chronic IS | 12 | BM-MNCs/autologous | Not provided | IV | 3-24 months | 4 years | No side effects. Significant improvements in mBI at 156 and 208 weeks | [214] |
RCT: random control trial; OL-PT: open label prospective trial; SB-CT: simple blinded control trial; IV: intravenous; IA: intra-arterial; IC: intracerebral; adm: administration.