Review of Preclinical and Clinical Studies of Bone Marrow-Derived Cell Therapies for Intracerebral Hemorrhage

Table 2

Trials with published clinical results.

Study reference/country	Cell type	Route	Study design	Stroke type	Age range (mean)	Time range from stroke to cell therapy	Number of treated patients with hemorrhagic stroke/total number of treated patients	Number of controls patients with hemorrhagic stroke/total number of control patients	Number of transplanted cells	Infusion volume, duration, and rate	Follow-up
Suarez-Monteagudo et al., 2009/Cuba [74]	Autologous BM-MNC	IC	Case series, nonrandomized, open-label	Ischemic or hemorrhagic in thalamus, basal ganglia, or cortex	41–64 (mean 51.4)	3 to 8 years (mean 5 years)	2/5	None	1.7 × 10^7 to 5.5 × 10^7 (mean 3.6 × 10^7)	8 seeds of 2.5 µL	12 months
Bhasin et al., 2011/India [76]	Autologous BM-MSC	IV	Case control, nonrandomized, open-label	MCA ischemic or hemorrhagic stroke	Mean 45	Mean 9.6 months	2/6	1/6	5 × 10^7 to 6 × 10^7	250 mL in 3 h (1.4 mL/min)	6 months
Li et al., 2013/China [75]	Autologous BM-MNC	IC	Phase 1, nonrandomized, single-blind	Basal ganglia hemorrhagic stroke	39–74 (mean 56.3)	5 to 7 days (mean 5.9 days)	60/60	40/40	2.5 × 10^8 to 2.3 × 10^9 (median 1.3 × 10^9)	3.5 mL; duration not specified	6 months
Sharma et al., 2014/India [77]	Autologous BM-MNC	IT	Phase 1, nonrandomized, open-label	Ischemic or hemorrhagic stroke	27–79 (mean 57)	4 to 144 months (mean 40.5)	10/24	None	Body weight × 10^6	Not specified	6 to 54 months (mean 30)
Zhu et al., 2015/China [78]	Autologous BM-MNC (IC) and BM-MSC (IT)	IC and IT	Not specified	Basal ganglia hemorrhagic stroke	32–75 (mean 57.2)	IC injection (BM-MNC): 3.01 to 6.89 days (mean 5.5)/IT injection (BM-MSC) after 4 weeks	114/114	96/96	Mean 2 × 10^9 BM-MNCs/mean 8.4 × 10^7 BM-MSC	5 mL for IC injection	12 months

IC: intracerebral; IV: intravenous; IT: intrathecal; BM-MNC: bone marrow mononuclear cells; BM-MSC: bone marrow-derived mesenchymal stem cells; MCA: middle cerebral artery.