RT Journal Article
SR Electronic
T1 Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP e1012
OP e1023
DO 10.1212/WNL.0000000000011440
VO 96
IS 7
A1 Chung, Jong-Won
A1 Chang, Won Hyuk
A1 Bang, Oh Young
A1 Moon, Gyeong Joon
A1 Kim, Suk Jae
A1 Kim, Soo-Kyoung
A1 Lee, Jin Soo
A1 Sohn, Sung-Il
A1 Kim, Yun-Hee
A1 ,
YR 2021
UL http://n.neurology.org/content/96/7/e1012.abstract
AB Objective To test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.Methods In this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.Results A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious treatment-related adverse events.Conclusions IV application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of Evidence This study provides Class III evidence that autologous MSCs do not improve 90-day outcomes in patients with chronic stroke.ClinicalTrials.gov Identifier NCT01716481.BBB=blood-brain barrier; CI=confidence interval; CST=corticospinal tract; DTI=diffusion tensor imaging; FAC=Functional Ambulatory Category; FBS=fetal bovine serum; FMA=Fugl-Meyer Assessment; FMA-LL=FMA lower limb; FMA-T=FMA total; FMA-UL=FMA upper limb; ITT=intention-to-treat; MEP=motor evoked potential; MI=Motricity Index; mRS=modified Rankin Scale; MSC=mesenchymal stem cell; NIIHSS=NIH Stroke Scale; STARTING=Stem Cell Application Researches and Trials in Neurology