Table 2.
Ongoing and pending trials of cell therapy for stroke
| Clinical Trials ID [Reference ] |
Sponsor / Location |
Cell Number / Type / Route |
Age | Infarct Severity/Type |
Treatmen t Window |
n | Phase | Primary outcome |
Rando mized? |
Blinding | Start Date |
End Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00473 057 [109] |
Federal University of Rio de Janeiro, Brazil |
500 million / Autologous BMMC / IA versus IV |
18 – 75 |
NIHSS 4 – 20 | 3 – 90 days |
15 | I | Neurologi c deficits |
No | Open Label |
Decemb er 2005 |
June 2011 |
| NCT00535 197 [110] |
Imperial College London, UK |
na/ Autologous CD34+ cells from bone marrow / IA |
30 – 80 |
Total anterior circulation syndrome |
<7 days | 10 | I/II | Toxicity | No | Open Label |
Septem ber 2007 |
June 2010 |
| NCT00593 242 [111] |
Duke University, NC, USA |
5 million cells/kg / Autologous cord blood / IV |
<14d ays |
Neonatal hypoxic / ischemic injury |
<14 days | 12 | I | Adverse events |
No | Open Label |
January 2008 |
Januar y 2011 |
| NCT01028 794 [112] |
National Cardiovascular Center, Osaka, Japan |
25 or 50 cc bone marrow / autologous BMMCs / IV |
20 – 75 |
NIHSS >9 | 7 – 10 days |
12 | I/IIA | NIHSS | No | Open label | May 2008 |
March 2012 |
| NCT00761 982 [113] |
Hospital Universitario Central de Asturias, Spain |
na / Autologous CD34+ cells from bone marrow / IA |
18 – 80 |
NIHSS >7; MCA |
5 – 9 days | 20 | I/II | Adverse events |
No | Single- blind (assessor) |
Septem ber 2008 |
March 2010 |
| NCT00859 014 [114] |
The University of Texas Health Science Center, Houston, USA |
na/ Autologous BMMCs / IV |
18 – 80 |
R: NIHSS 6 – 15; L NIHSS 6 – 18 |
24 – 72 hours |
10 | I | Safety, feasibility |
No | Open label | January 2009 |
Januar y 2014 |
| NCT00950 521 [115] |
China Medical University Hospital, Taichung, Taiwan |
2 – 8 million / Autologous CD34+ cells from peripheral blood / IC |
35 – 70 |
NIHSS 9 – 20 | 6 – 60 months |
30 | II | NIHSS | Yes | Open label | June 2009 |
Decem ber 2010 |
| NCT01019 733 [116] |
Hospital Universitario, Nuevo Leon, Mexico |
8 – 10cc bone marrow / CD34+ cells post G-CSF / IT |
1 mont h –18 years |
Cerebral palsy | 1 month – 18 years |
10 | I | Battelle Devel. Inventory |
No | Open label | July 2009 |
August 2010 |
| NCT01091 701 [117] |
Stempeutics Research Pvt Ltd, Malaysia |
2 million cells/kg / adult allogenic MSCs IV |
20 – 80 |
mRS <5 with motor weakness |
<10 days | 78 | I/II | Adverse events, NIHSS |
Yes | Double blind |
May 2010 |
Decem ber 2011 |
| NCT01151 124 [118] |
ReNeuron, Ltd, Glasgow, UK |
2, 5, 10, 20 million / CTX0E03 neural stem cells / IC |
60 – 85 |
NHSS>5; Subcortical white matter or basal ganglia; |
6 – 24 months |
12 | I | Adverse effects, MRI, NIIHSS, antibodies |
No | Open label | June 2010 |
na |
| NCT00875 654 [119] |
University Hospital, Grenoble, France |
na / Autologous MSCs / IV |
18 – 65 |
NIHSS>2 | <14 days | 30 | II | Feasibility, tolerance |
Yes | Open label | Septem ber 2010 |
Decem ber 2013 |
| NCT00908 856 [120] |
University of California, Irvine, CA, USA |
30 cc bone marrow / autologous BMMCs / IV |
18 – 85 |
NIHSS 7 – 24; supratentorial |
2 – 21 days |
33 | II | Mortality | Yes | Double blind |
January 2011 |
Decem ber 2012 |
| na | SanBio Inc., Mountain View, CA, USA |
2.5, 5.0, 10 million / SB623 cells – modified* BMMCs / IC |
18 – 75 |
mRS 3 – 4; ESS 40 – 50; Subcortical MCA or striatum +/− cortex |
6 – 12 months |
18 | I/II | Adverse effects, acute and long-term safety |
No | Open label | January 2011 |
na |
BMMC: bone marrow mononuclear cells, ESS: European Stroke Scale, IA: intra-arterial, IC: intracerebral, IV: intravenous, MCA: middle cerebral artery, MSC: mesenchymal stem cells, na: not available, NIHSS: National Institutes of Health Stroke Scale.
*
Transient Notch 1 transfection.