Table 2.
Completed and active clinical trials using cell therapy to treat stroke.
| Trial number | Trial name | Current status | Study start and end date | Duration [y] | Phase | Sponsor | No. of participants | Cell type | Cell dose | Route | Time from stroke onset | References | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| COMPLETED | |||||||||||||
| 1 | NCT00152113 | Compl | 2005–2008 | 3 | 1 | Research Hospital | 5 | Hematopoietic Stem Cell | 5 × 106 CD34+/kg, 1 × 106 CD3+/kg | IV | Prophylactic | (45) | |
| 2 | NCT00473057 | Compl | 2005–2011 | 6 | 1 | University/College | 12 | Autologous BMSCs | 500 million | IA | 90 days | ||
| 3 | NCT00535197 | Compl | 2007–2012 | 5 | 1,2 | University/College | 5 | Autologous BMSCs | Max. 1 × 108 | IA | <7 days | (46) | |
| 4 | NCT01501773 | Compl | 2008–2011 | 3 | 2 | Industry | 120 | Autologous BMSCs | 30–500 million | IV | 7–30 days | (44, 47) | |
| 5 | NCT00761982 | Compl | 2008–2011 | 3 | 1,2 | University Hospital | 20 | Autologous BMSCs | 1.59 × 108 | IA | 5–9 days | (48) | |
| 6 | NCT00950521 | Compl | 2009–2010 | 1 | 2 | University Hospital | 30 | Hematopoietic CD34+ stem cells | 2–8 million | ICb | 6–60 months | (49) | |
| 7 | NCT02425670 | InVeSt | Compl | 2009–2010 | 1 | 2 | Research Institute | 120 | Autologous BMSCs | 30–500 million | IV | 7–29 days | (47) |
| 8 | NCT00859014 | Compl | 2009–2013 | 4 | 1 | University/College | 25 | Autologous BMSCs | 10 × 106/kg | IV | 24–72 h | (50) | |
| 9 | NCT00875654 | ISIS-HERMES | Compl | 2010–2017 | 7 | 2 | Hospital | 31 | Autologous mesenchymal stem cells | 100 or 300 million | IV | <6 weeks | |
| 10 | NCT01287936 | SanBio | Compl | 2011–2015 | 4 | 1,2 | Industry | 18 | Autologous modified Stromal Cells (SB623) | 2.5, 5.0, or 10 million | IC | 6–60 months | (51) |
| 11 | NCT01436487 | MASTERS-1 | Compl | 2011–2015 | 4 | 2 | Industry | 134 | Allogenic BMSCs (MultiStem) | 400 or 1200 million | IV | 24–48 h | (52, 53) |
| 12 | NCT01297413 | Compl | 2011–2017 | 6 | 1,2 | Research Institute | 20 | Allogenic BMSCs | 0.5–1.5 × 106/kg | IV | >6 months | ||
| 13 | NCT02117635 | PISCES-II | Compl | 2014–2016 | 2 | 2a | Industry | 23 | Allogenic NSCs (CTX DP) | 20 million cells | ICb | <4 weeks | (38) |
| 14 | NCT01678534 | AMASCIS-01 | Compl | 2014–2018 | 4 | 2 | University Hospital | 19 | Allogenic ADSCs | 1 million units/kg | IV | <2 weeks | (54) |
| 15 | NCT03080571 | Compl | 2015–2016 | 1 | 1 | Industry | 38 | Autologous intra-arterial BM-MNCs | – | IA | 0–15 days | ||
| 16 | NCT02397018 | CoBIS1 | Compl | 2015–2017 | 2 | 1 | Research Institute | 124 | Allogeneic umbilical cord blood stem cells | 0.5–5 × 107/kg | IV | 3–10 days | (55) |
| 17 | NCT02813512 | Compl | 2017–2018 | 1 | 1 | Industry | 3 | Autologous ADSCs | – | ICb | >6 months | ||
| ACTIVE | |||||||||||||
| 1 | NCT01151124 | PISCES | Not recr | 2010–2023 | 13 | 1,2 | Industry | 12 | Allogenic NSCs (CTX DP) | 2, 5, 10, or 20 million | ICb | 6 months to 5 years | (38) |
| 2 | NCT01716481 | STARTING-2 | Recr | 2012–2017 | 5 | 3 | Industry | 60 | Autologous MSCs | 1 × 106cells/kg | IV | <90 days | (56) |
| 3 | NCT03296618 | Not recr | 2012–2018 | 6 | 1 | Industry | 18 | NSCs (NSI-566) | 1.2 × 107-8 × 107 | IC | 3–24 months | ||
| 4 | NCT02178657 | IBIS | Recr | 2014–2018 | 4 | 2 | Research Institute | 76 | Autologous bone marrow mononuclear cells | 2 or 5 × 106/kg | IA | 1–7 days | (57) |
| 5 | NCT02448641 | ACTIsSIMA | Not recr | 2016–2019 | 3 | 2 | Industry | 156 | Autologous modified Stromal Cells (SB623) | 2.5 or 5 million | IC | 6–90 months | |
| 6 | NCT02795052 | NEST | Recr | 2016–2020 | 4 | n.d. | Industry | 300 | Autologous BMSCs | – | IV, IN | >6 months | |
| 7 | NCT03371329 | Recr | 2017–2018 | 1 | 1 | Hospital | 12 | Allogenic BMSCs | 0.5, 1, 2 × 106/kg | IV, IT | <72 h | ||
| 8 | NCT03004976 | CoBIS2 | Recr | 2017–2019 | 2 | 2 | Research Institute | 100 | Allogeneic umbilical cord blood infusion | 0.5–5 × 107/kg | IV | 3–10 days | |
| 9 | NCT03629275 | PISCESIII | Recr | 2018–2019 | 1 | 2b | Industry | 110 | Allogenic NSCs (CTX0E03) | 20 million | ICb | 6–12 months | |
| 10 | NCT03545607 | MASTERS-2 | Recr | 2018–2020 | 2 | 3 | Industry | 300 | Allogenic BMSCs (MultiStem) | 1.2 billion | IV | 24–36 h | (53) |
| 11 | NCT03570450 | RESSTORE-1 | Recr | 2018–2020 | 2 | 1 | University Hospital | 15 | ADSCs | 1.1, 2.1, 2.5, 3.1 × 106/kg | IV | 24–48 h | |
| 12 | NCT02961504 | TREASURE | Recr | 2017–2020 | 3 | 2,3 | Industry | 220 | Allogenic BMSCs, HLCM051 (MultiStem) | 1.2 billion | IV | 18–36 h | |
| 13 | ACTRN12618000076279 | I-ACT | Recr | 2019–2021 | 3 | 1 | Research Institute | 15 | Allogenic hAECs | 2, 4, 8, 16, 32 million/kg | IV | <24 h | (39) |
IV, intravenous; IT, intrathecal; IA, intra-arterial; IC, intracrainial; ICb, intracerebral; IN, intranasal.