Skip to main content

Table 1 Clinical trials of stem cell therapy in stroke patients

From: Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial

Factors Neural stem/progenitor cells Bone marrow mononuclear cells Mesenchymal stem cells
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 cellsa 1 × 106 cells/kga 2.2 × 108 cellsa 1 × 108 cellsa 1 × 108 cellsa 1 × 108 cellsa 5 to 6 × 107 cellsa
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)
FDAb More than minimal manipulation Minimal manipulation More than minimal manipulation
ICMSc 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
  1. aEquivalent to preclinical studies.
  2. bUS Food and Drug Administration (FDA) regulation on cell therapy.
  3. cClinical staging for cell lines by the International cellular medicine society (ICMS).
  4. f/u follow-up, mRS modified Rankin Score, MSC mesenchymal stem cell, NIHSS National Institutes of Health Stroke Scale, PCR polymerase chain reaction.