The potential benefit of stem cell therapy after stroke: an update

Figures & data

Figure 1 Stem cell types used in stroke trials, and the proposed mechanisms of action.

Abbreviations: UCB, umbilical cord blood; NSC, neuronal stem cell; BMMNC, bone marrow mononuclear cell; HSC, hematopoietic stem cell; MSC, mesenchymal stem cell.

Table 1 Summary of ongoing or completed (but unreported) chronic stroke trials

Cell type	Study design	Expected no of patients	Timing of delivery poststroke	Route of delivery	Clinical trial identifier	Trial status
Chronic trials (>4 weeks postevent)
CTX0E03 neural stem cells	PI, NR-OL	12	6 months–5 years	IC	NCT01151124	Recruiting
MSCs	PII, R-OL	30	<6 weeks	IV	NCT00875654	Recruiting
CD34^+	PII, R-OL	30	6–60 months	IC	NCT00950521	Complete
CD34^+	PI, NR-OL	6	6–60 months	IC	NCT01438593	Not yet recruiting
CD34^+	PI, R-OL	40	<1 year	IA	NCT01518231	Recruiting
MSCs, EPCs	PI/II, R-DB	90	5 weeks	IV	NCT01468064	Recruiting
MSCs	PII, R-OL	50	1 week–2 months	IV	NCT01461720	Recruiting
MSCs	PI/II, NR-OL	35	>6 months	IV	NCT01297413	Recruiting
SB623	PI/II, NR-OL	18	6–36 months	Unclear	NCT01287936	Recruiting
OECs	PI, R-SB	6	6 months–5 years	IC	NCT01327768	Recruiting

Note: CTX0E03 and SB623 are commercially developed stem cell lines.

Abbreviations: BMMNC, bone marrow mononuclear cells; MSCs, mesenchymal stem cells; OECs, olfactory ensheathing cells; EPCs, endothelial progenitor cells; NR, nonrandomized; OL, open-label; PI and II, phase I and II trials; R, randomized; SB, single-blind; DB, double-blind; IV, intravenous; IA, intra-arterial; IC, intracerebral.

Table 2 Summary of ongoing or completed (but unreported) acute/subacute stroke trials

Cell type	Study design	Expected no of patients	Timing of delivery poststroke	Route of delivery	Clinical trial identifier	Trial status
Acute and subacute trials (<4 weeks postevent)
BMMNC	PII, R-OL	120	7–30 days	IV	NCT01501773	Complete
MSCs	PII, NR-OL	120	7–14 days (infarct) or 10–21 days (ICH)	IV, then intrathecal 7 days later	NCT01389453	Recruiting
CD34^+	PI/II, NR-OL	10	7 days	IA	NCT00535197	Recruiting
MSCs	PI/II, R-DB	78	<10 days	IV	NCT01091701	Not yet recruiting
MultiStem	PII, R-DB	140	1–2 days	IV	NCT01436487	Recruiting
ALD-401	PI/II, R-DB	100	13–19 days	IA	NCT01273337	Recruiting

Note: MultiStem and ALD-401 are commercially developed stem cell lines.

Abbreviations: BMMNC, bone marrow mononuclear cells; MSCs, mesenchymal stem cells; OECs, olfactory ensheathing cells; EPCs, endothelial progenitor cells; NR, nonrandomized; OL, open-label; PI and II, phase I and II trials; R, randomized; SB, single-blind; DB, double-blind; IV, intravenous; IA, intra-arterial; IC, intracerebral; ICH, intracerebral hemorrhage.

Figure 2 Stroke Therapy Academic Industry Roundtable (STAIR) II recommendations. Adapted from Stroke Therapy Academic Industry Roundtable II (STAIR-II). Recommendations for clinical trial evaluation of acute stroke therapies. Stroke. 2001;32:1598–1606.⁸³

Note: Important factors relevant to stem cell therapy underlined.

Figure 3 Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS) recommendations.

Adapted from Stem Cell Therapies as an Emerging Paradigm in Stroke participants. Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS): bridging basic and clinical science for cellular and neurogenic factor therapy in treating stroke. Stroke. 2009;40:510–515.⁸⁵

Stroke Therapy Academic Industry Roundtable II (STAIR-II)Recommendations for clinical trial evaluation of acute stroke therapiesStroke2001321598160611441207

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Stem Cell Therapies as an Emerging Paradigm in Stroke participants. Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS): bridging basic and clinical science for cellular and neurogenic factor therapy in treating strokeStroke20094051051519095993

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