Table 3.
Clinical trials using stem cell therapies for acute ischemic stroke [108].
| Trial Identifier | Phase | Status | Stem Cell Types Used | Protocol |
|---|---|---|---|---|
| Neural stem cells | ||||
| NCT01151124 (PISCES) | 1 | active, not recruiting | NSCs, CTX0E03 line | Intracerebral delivery of increasing doses 6 months to 5 years post-stroke |
| NCT02117635 (PISCES-II) | 2 | completed | Allogeneic NSCs, CTX-derived precursor cells | Intracerebral transplantation of 20 × 106 cells 2–3 months post-stroke |
| NCT04631406 | 1 | recruiting | Human ESC-derived NR1 cells | Intracerebral graft of increasing doses of cells 6 to 60 months post-stroke |
| Mesenchymal stem cells | ||||
| NCT03080571 | 1 | completed | Autologous BM-derived MSCs | Intra-arterial delivery of an unspecified number of MSCs within 15 days post-stroke |
| NCT00859014 | 1 | completed | Autologous mononuclear BM-derived stem cells | Intravenous delivery of 10 × 106 cells within 24–72 h post-stroke |
| NCT004097652 | 1 | completed | Allogeneic UC-derived MSCs | Intravenous delivery of 3 different doses of cells within 48–168 h post-stroke |
| NCT00473057 | 1 | completed | Autologous BM-MSCs | 500 × 106 cells delivered IA in up to 10 patients and IV in up to 5 patients within 3–90 days post-stroke |
| NCT04434768 | 1 | recruiting | Allogeneic UC-MSCs (UMSC01) | Two arms: intravenous or intravenous and intra-arterial delivery following thrombolysis within 36 h after stroke onset |
| NCT02397018 | 1 | completed | Allogeneic cord blood infusion | 0.5–5 × 107 cells/kg within 3–10 days post-stroke |
| NCT02433509 | 1 | recruiting | Allogeneic human UC-derived monocytes | 200–500 × 106 cells delivered as IV infusion within 10 days from stroke onset |
| NCT01297413 | 1/2 | completed | Allogeneic BM-MSCs | 0.5–1.5 × 106 cells/kg delivered IV within 6 months |
| NCT05292625 | 1/2 | recruiting | Allogeneic UC-MSCs | 1.5 × 106 cells/kg delivered IV or intrathecal in stroke patients within 24 months post-stroke, repeated after 3 months |
| NCT01287936 | 1/2 | completed | Allogeneic modified stem cells (SB623 cell line) | Three arms with doses ranging between 2.5–5 × 106 cells with stereotactic intracerebral delivery 6 to 60 months post-stroke |
| NCT02605707 | 1/2 | completed | Autologous endothelial progenitor cells | IV, 6 to 60 months post-stroke, number of cells not stated |
| NCT00535197 | 1/2 | completed | Autologous CD34+ BM-MSCs | Intra-arterial delivery into the ipsilateral MCA within 7 days post-stroke; non-specified number of cells |
| NCT04608838 (J-REPAIR) | 1/2 | completed | Allogeneic dental pulp stem cells | 1 or 3 × 108 cells delivered IV within 48 h from stroke onset |
| NCT01468064 (AMETIS) | 1/2 | completed | Autologous BM and endothelial progenitor cells (EPCs) | Either 2.5 × 106 BM-MSCs or 2.5 × 106 EPCs delivered IV within 4 weeks after stroke onset |
| NCT04590118 (ASSiST) | 1/2 | recruiting | Allogeneic human MSCs | 0.5 × 106, 1 × 106, or 2 × 106 MSCs delivered IV more than 6 months after stroke onset |
| NCT03915431 | 1/2 | recruiting | Allogeneic BM-MSCs (NCS-01) | Various number of cells delivered IV within 24 h after stroke onset |
| NCT04093336 | 1/2 | recruiting | Allogeneic human UC-MSCs | 2 × 106 cells/kg transplanted IV within 24 h post-stroke onset |
| NCT05008588 | 1/2 | recruiting | UC-MSCs + conditioned medium | Intranasal delivery of conditioned medium for 3 days followed by intraparenchymal transplant of 20 × 106 MSCs or just intraparenchymal transplant in ischemic stroke patients (time window not specified) |
| NCT04811651 | 2 | recruiting | UC-MSCs | IV delivery of 100 × 106 cells in 5 groups: between 6 and 24 h from stroke onset; 1–3 days post-stroke; 4–7 days post-stroke; 1–4 weeks post-stroke; 1–6 months post-stroke |
| NCT01678534 (AMASCIS-01 | 2 | completed | Allogeneic adipose tissue-derived MSCs | 106/kg delivered IV within 2 weeks from stroke onset |
| NCT02178657 | 2 | active, not recruiting | Autologous BM-MSCs | 2 × 106 and 5 × 106 cells/kg delivered IA within 7 days from stroke onset |
| NCT04280003 | 2 | recruiting | Allogeneic adipose tissue- derived MSCs | 106 cells/kg delivered IV within 4 days from stroke onset |
| NCT02448641 (ACTISSIMA) | 2 | completed | Modified stem cells (SB623 cell line) | Intraparenchimatous implant of 2.5 × 106 and 5 × 106 cells, 6 to 90 months post-stroke |
| NCT01501773 | 2 | completed | Autologous BM-MSCs | 30–500 × 106 mononuclear cells delivered IV within 7–30 days post-stroke |
| NCT02425670 | 2 | completed | Autologous BM-MSCs | 30–500 × 106 cells injected IV within 7–30 days from stroke onset |
| NCT03004976(CoBIS2) | 2 | completed | Allogeneic umbilical cord blood | 0.5–5 × 107 cells/kg delivered IV within 3–10 days from stroke onset |
| NCT00875654 (ISIS) | 2 | completed | Autologous MSCs | IV delivery within 6 weeks from stroke onset; number of cells not stated, 2 different doses will be used |
| NCT01436487 | 2 | completed | MULTISTEM investigational adult stem cells | Three different doses of cells delivered IV within 1–2 days from stroke onset |
| NCT02961504 (TREASURE) | 2/3 | active, not recruiting | Regenerative cell elements (HLCM051) | 1.2 × 109 cells delivered IV 18–36 h after stroke onset |
| NCT03545607 (MASTERS-2) | 3 | recruiting | Allogeneic adult stem cells (MULTISTEM) | 1.2 × 109 cells infused IV within 18–36 h after stroke onset |
NSCs—neural stem cells; MSCs—mesenchymal stem cells; UC—umbilical cord; BM—bone marrow; IV—intravenous; IA—intra-arterial.