Table 1 Clinical trials of stem cell therapy in stroke patients

Lead author, year, reference

Savitz, 2005 [2]

Savitz, 2011 [4]

Friedrich, 2012 [5]

Bang, 2005 [6]

Lee, 2010 [7] (STARTING trial)

Honmou, 2011 [8]

Bhasin, 2011 [9]

Study design

No control group

No control group

No control group

Control, n = 25

Control, n = 36

No control group

Control, n = 6

Treatment, N = 5

Treatment, N = 10

Treatment, N = 20,

Treatment, n = 5

Treatment, n = 16

Treatment, n = 12

Treatment, n = 6

4 years f/u

6 months f/u

6 months f/u

1 year f/u

5 years f/u

1 year f/u

24 weeks

Brain infarct

Chronic basal ganglia infarct

Acute (24 to 72 h), large hemispheric

Acute (3 to 7 days), non-lacunar

Subacute, large cortical

Subacute, large cortical

Chronic (36 to 133 days), large cortical

Chronic (3 months to 1 year)

Cells used

Neural progenitor cells from primordial porcine striatum

Autologous bone marrow mononuclear cells

Autologous bone-marrow-derived mesenchymal stem cells

Cell dose

2 × 10⁷ cells^a

1 × 10⁶ cells/kg^a

2.2 × 10⁸ cells^a

1 × 10⁸ cells^a

1 × 10⁸ cells^a

1 × 10⁸ cells^a

5 to 6 × 10⁷ cells^a

Manipulation

Fetal porcine striatum was washed, triturated, and dissociated to yield cell suspensions

Isolation using human albumin-containing normal saline

Ex vivo culture expansion using fetal bovine serum

Ex vivo culture expansion using autologous serum

Ex vivo culture expansion using animal serum-free media (Stem Pro SFM)

FDA^b

More than minimal manipulation

Minimal manipulation

More than minimal manipulation

ICMS^c

Early investigational cell line

Clinical grade

Clinical grade

Clinical grade

Clinical grade

Mode of application

Intralesional

Intravenous

Intraarterial

Intravenous

Presumed mechanisms

Cell replacement and trophic support

Trophic support

Trophic support

Efficacy

Not available

mRS 1 shift vs historical control

Good outcome (mRS 0 to 2) in 40%

Barthel index improved at 3 months

Proportion of mRS 0 to 3 increased in MSC but not control group

Improve in daily rate of NIHSS changes

Modest increase in Fugl-Meyer and mRS

Adverse effect

1 seizure, 1 worsening of weakness

None

None

None

None

None

None

Safety test

Cell viability PCR testing for porcine endogenous retrovirus

Cell viability MSC surface markers; bacteria, fungi, mycoplasma culture.

Cell viability

Cell viability MSC surface markers; bacteria, fungi, viral and mycoplasma culture.

Cell viability, MSC surface markers; bacteria, syphilis, fungi, viral, mycoplasma, endotoxin level.

Cell viability; mycoplasma, endotoxin level