• Kameshwar Prasad, Alka Sharma, Ajay Garg, Sujata Mohanty, Shinjini Bhatnagar, Sharat Johri, Kunwar Karni Singh, Velu Nair, Ravi Shankar Sarkar, Sankar Prasad Gorthi, Kaukab Maqbool Hassan, Sudesh Prabhakar, Neelam Marwaha, Niranjan Khandelwal, Usha Kant Misra, Jayantee Kalita, Soniya Nityanand, and InveST Study Group.
• From the All India Institute of Medical Sciences, New Delhi, India (K.P., A.G., S.M., S.B.); Department of Biotechnology, Ministry of Science and Technology, Government of India, New Delhi, India (A.S.); Army Hospital Research & Referral, New Delhi, India (S.J., K.K.S., V.N.); Armed Forces Medical College, Pune, India (R.S.S., S.P.G., K.M.H.); Postgraduate Institute of Medical Education & Research, Chandigarh, India (S.P., N.M., N.K.); and Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India (U.K.M., J.K., S.N.). drkameshwarprasad@gmail.com.
• Stroke. 2014 Dec 1;45(12):3618-24.

Background And PurposePilot studies have suggested benefit from intravenous administration of bone marrow mononuclear stem cells (BMSCs) in stroke. We explored the efficacy and safety of autologous BMSCs in subacute ischemic stroke.MethodsThis was a phase II, multicenter, parallel group, randomized trial with blinded outcome assessment that included 120 patients. Patients with subacute ischemic stroke were randomly assigned to the arm that received intravenous infusion of autologous BMSCs or to control arm. Coprimary clinical efficacy outcomes were Barthel Index score and modified Rankin scale at day 180. Secondary outcomes were change in infarct volume, National Institute of Health Stroke Scale (NIHSS) at day 90 and 180. Main safety outcomes were adverse events, any new area of (18)fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days.ResultsFifty-eight patients received a mean of 280.75 million BMSCs at median of 18.5 days after stroke onset. There was no significant difference between BMSCs arm and control arm in the Barthel Index score (63.1 versus 63.6; P=0.92), modified Rankin scale shift analysis (P=0.53) or score >3 (47.5% versus 49.2%; P=0.85), NIHSS score (6.3 versus 7.0; P=0.53), change in infarct volume (-11.1 versus -7.36; P=0.63) at day 180. Adverse events were also similar in the 2 arms, and no patient showed any new area of (18)fluorodeoxyglucose uptake.ConclusionsWith the methods used, results of this hitherto first randomized controlled trial indicate that intravenous infusion of BMSCs is safe, but there is no beneficial effect of treatment on stroke outcome.Clinical Trial RegistrationURLs: http://ctri.nic.in/Clinicaltrials and http://www.clinicaltrials.gov. Unique identifiers: CTRI-ROVCTRI/2008/091/0004 and NCT0150177.© 2014 American Heart Association, Inc.

20 keywords...

hide…