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. 2013 Mar 19;22(15):2095–2111. doi: 10.1089/scd.2013.0089

Table 1.

Trials with Published Clinical Results

Study reference/Country Study design Route Cell type Type of stroke Age range (mean) Time range from stroke onset to transplantation No. of treated patients (No. of controls) No. of cells injected Infusion volume, rate and duration Follow-up
Kondziolka et al., 2000/United States Phase I, nonrandomized, single-blind IC NT2N cells Ischemic stroke in basal ganglia (8 cases) or cortex and basal ganglia (4 cases) 44–75 7 to 55 months (mean 27 months) 12 (no controls) 2×106 (8 patients); 6×106 (4 patients) Not specified 52–60 months
Rabinovich et al., 2005/Russia Case series, nonrandomized, open label IT Human Fetal Cells Hemorrhagic (3 cases) in MCA and ischemic (7 cases) in MCA or MCA+ACA 35–56 4 to 24 months (mean 12.1 months) 10 (10 historical controls) 1 (5 patients) or 2 (5 patients) infusions of 2×108 Not specified 6 months
Kondziolka et al., 2005/United States Phase II, randomized, single-blind IC NT2N cells Ischemic (9 cases) or hemorrhagic (9 cases) involving basal ganglia 40–70 1 to 5 years (mean 3.5 years) 14 (4 controls without injection) 5×106 (7 patients); 1×107 (7 patients) Not specified 18 to 29 months
Savitz et al., 2005/United States Phase I, nonrandomized, open label IC Fetal Porcine cells Ischemic involving the striatum 25–52 (mean 39.8) 4 to 10 years (mean 4.9 years) 5 (no controls) Up to 5 injections of 107 10 μL/min, 106 cells/μL 4 years
Man et al., 2006/China Case series, nonrandomized, open label IV Allogeneic UC-MNCs Ischemic (6 cases) or hemorrhagic (4 cases) 35–75 (mean 56) 3 months to 7 years (mean 23.5 months) 10 (no controls) 6 infusions of≥1×108, 1 to 7 days apart Not specified 3 months
Mendonca et al., 2006; Correa et al., 2007/Brazil Case reports on phase I, nonrandomized, open label IA Autologous BM-MNCs MCA ischemic stroke 54 and 37 5 (1 patient) and 9 days (1 patient) 2 (no controls) 1×108 (1 patient) and 3×107 (1 patient) 3 mL in 10 min (first patient) 2–4 months
Suarez-Monteagudo et al., 2009/Cuba Case series, nonrandomized, open label IC Autologous BM-MNCs Ischemic or hemorrhagic in thalamus, basal ganglia or cortex 41–64 (mean 51.4) 3 to 8 years (mean 5 years) 5 (no controls) 1.4×107to 5.5×107 (mean 3.4×107) 8 seeds of 2.5 μL 1 (4 cases) and 5 years (1 case)
Lee et al., 2010 (cont. of Bang et al., 2005)/South Korea Phase I/II, randomized, single-blind IV Autologous BM-MSCs MCA ischemic stroke Mean 64 Injections 19 to 37 days (median 32.5 days) and 2 weeks later 16 (36 controls without injection) 5×107 (2 doses 2 weeks apart) Not specified 5 years
Battistella et al., 2011; Rosado-de-Castro et al., 2013/Brazil Phase I, nonrandomized, open label IA or IV Autologous BM-MNCs MCA ischemic stroke 24–68 (mean 58.5) 19 to 89 days (mean 64.5) 12 (no controls) 1×108 to 5×108 (mean 3.1×108) 10 mL in 10 min (1 mL/min) 6 months
Honmou et al., 2011/Japan Phase I, nonrandomized, open label IV Autologous BM-MSCs Ischemic gray matter, white matter and mixed lesions 41–73 (mean 59.2) 36 to 133 days (mean 68 days) 12 (no controls) 0.6×108 to 1.6×108 (mean 1.1×108) In 30 min; volume not specified 12 months
Savitz et al., 2011/United States Phase I, nonrandomized, open label IV Autologous BM-MNCs MCA ischemic stroke Mean 55 24 to 72 h 10 (79 historical controls) 7×108/kg to 1×109/kg (mean 9.6×108/kg) In 30 min; volume not specified 6 months
Han et al., 2011/South Korea Not specified IT Allogeneic UC-MSCs Ischemic in pons, midbrain and right superior cerebellum 17 35 days 1 (no controls) 3.6×107 Not specified 2 months
Bhasin et al., 2011, 2012a, 2012b/India Phase I, nonrandomized, single-blind (fMRI) IV Autologous BM-MSCs or BM-MNCs MCA ischemic or hemorrhagic stroke Mean 45 mean 9.6 months 20 (14 BM-MNC group; 6 BM-MSC group; 20 controls without injection) 5×107 to 6×107 250 mL in 3 h (1.4 mL/min) 6 months
Friedrich et al., 2012/Brazil Phase I/II, nonrandomized, single-blind (CT) IA Autologous BM-MNCs MCA ischemic stroke 30–78 (mean 63) 3 to 10 days (mean 6 days) 20 (no controls) 5.1×107 to 6×108 (mean 2.2×108) 15 mL in 30 min (0.5 mL/min) 6 months
England et al., 2012, United Kingdom Subgroup of phase IIb, randomized, controlled trial with IV Autologous CD34+ PB-HPSCs Ischemic stroke Not specified for sub-group 3 to 30 days 8 (6 G-CSF group; 2 placebo group; no controls) 2×107 to 4.3×108 Not specified 3 months
Sharma et al., 2012/India Not specified IT Autologous BM-MNCs Left thalamic hemorrhagic stroke 69 1 year 1 (no controls) 5×107 Not specified Not specified
Moniche et al., 2012/Spain Phase I/II, nonrandomized, single-blind IA Autologous BM-MNCs MCA ischemic stroke Mean 66.9 5 to 9 days (mean 6.4 days) 10 (10 controls without injection) mean 1.6×108 0.5 to 1 mL/min; duration not specified 6 months
Prasad et al., 2012/India Phase I, nonrandomized, open label IV Autologous BM-MNCs MCA or MCA+ACA ischemic stroke 30–70 (mean 51.5) 8 to 29 days (mean 17 days) 11 (no controls) 1.9×108 to 1.9×109 (mean 8×107) In 5 min; volume not specified 12 months
Li et al., 2012/China Phase I, nonrandomized, single-blind IC Autologous BM-MNCs Basal ganglia hemorrhagic stroke 39–74 (mean 56.3) 5 to 7 days (mean 5.9 days) 60 (40 controls with saline) 2.5×108 to 2.3×109 (median 1.3×109) 3.5 mL; duration not specified 6 months
Jiang et al., 2012/China Phase I, non-randomized, open label IA Allogeneic UC-MSCs MCA ischemic (3 cases) or hemorrhagic (1 case) stroke 40–59 (mean 49) 11 to 50 days (mean 25.5) 4 (no controls) 2×107 20 mL in 20 min (1 mL/min) 6 months

IC, intracerebral; IA, intra-arterial; IV, intravenous; IT, intrathecal; BM-MNCs, bone marrow mononuclear cells; BM-MSCs, bone marrow-derived mesenchymal stem cells; UCB-MNCs, umbilical cord blood mononuclear cells; UC-MSCs, umbilical cord-derived mesenchymal stem cells; MCA, middle cerebral artery; ACA, anterior cerebral artery; NT2N, human teratocarcinoma-derived neurons; PB-HSPCs, peripheral blood hematopoietic progenitor/stem cells.

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