Table 2.
Summary of major reported clinical trials of stem cell transplantation in patients with hemorrhagic stroke
| Study | Country | Trial design | Number/age | Source | Dosage | Volume (mL) | Timing | Delivery route | Follow-up | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| Ahn et al. [2] (2018) | Korea | Phase I, open-label | H(9)/24–30 weeks | hUC-MSCs | 5×106/kg, 1×107/kg | 1–2/kg | 7 days | ICV | 2, 4, 6, 8 weeks | Safe and feasible; no adverse events |
| Tsang et al. [59] (2017) | China | Phase I/II, blinded, randomization | H(5), C(4)/48–56 years | Autologous BMSCs | 2.65×105 to 1.45×106/kg | 10 | 12 months | IV | 12, 16, 24, 36, 60 weeks | Safe; improvements in motor and cognitive function; no adverse events |
| Chang et al. [8] (2016) | China | Phase I/II, blinded, randomization | H(16), C(8)/30–75 years | Autologous BMSCs, UC-MSCs | 1.8×108 cells | N.C | 2, 3 weeks | IP | 3, 6, 12, 36, 60 months | Safe; improvements in NIHSS, mRS, and modified BI; no adverse events |
| Chen et al. [10] (2013) | China | Phase I/II, blinded, randomization | H(10)/42–87 years | OECs, NPCs, SCs, UC-MSCs | Various* | Various† | 1 week | IP, IT, IV‡ | 6–24 months | Safe and feasible; increased BI and CNIS; no adverse events |
| Li et al. [42] (2013) | China | Phase I/II, non-randomization | H(60), C(40)/35–74 years | Autologous BMSCs | 7.25×105 to 1.35×106/L | 3.5 | 5–7 days | IT | 6 months | Improvement in NIHSS and BI; one patient had lung cancer |
| Bhasin et al. [6] (2011) | India | Phase I/II, open-label | H(6), C(6)/20–60 years | BMSCs | 5–6×107 cells | 250 | 3–12 months | IV | 8, 24 weeks | Safe and feasible; no improvement; no adverse events |
Indicates OEC : 1×106; OEC+NPC : 1–2×106, 2–4×106; NPC : 2–5×106; NPC+SC : 2–5×106, 2×106; and UCMSCs : 1–2.3×107.
OEC, NPC/50 μL and NPC/500 μL + 5 mL CSF, UC-MSCs/100 mL.
IP (OECs, NPCs), IT (NPCs, SCs), and IV (UC-MSCs).
H : the number of hemorrhage patients, UC-MSCs : umbilical cord mesenchymal stromal cells, ICV : intracerebralventricle, C : the number of control patients, BMSCs : bone marrow mesenchymal stem cells, IV : intravenous, N.C : no comment, IP : intracranial parenchymal, NIHSS : National Institute of Health Stroke Scale, mRS : modified Rankin Scale, BI : Barthel Index, OEC : olfactory ensheathing cells, NPCs : neural progenitor cells, SCs : Schwann cells, IT : intrathecal, CNIS : clinic neurologic impairment scale