Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke

A multicentric, randomized trial

InveST Study Group

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Background and Purpose - Pilot 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.

Methods - This 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 18fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days.

Results - Fifty-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 18fluorodeoxyglucose uptake.

Conclusions - With 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.

Original languageEnglish
Pages (from-to)3618-3624
Number of pages7
JournalStroke
Volume45
Issue number12
DOIs
Publication statusPublished - 01-01-2014

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Cell- and Tissue-Based Therapy
Stem Cells
Bone Marrow
Stroke
National Institutes of Health (U.S.)
Intravenous Infusions
Safety
Human Body
Intravenous Administration
Positron-Emission Tomography
Randomized Controlled Trials
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialised Nursing

Cite this

@article{7890443f2d3740e59707f5be90d64b0f,
title = "Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: A multicentric, randomized trial",
abstract = "Background and Purpose - Pilot 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.Methods - This 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 18fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days.Results - Fifty-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 18fluorodeoxyglucose uptake.Conclusions - With 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.",
author = "{InveST Study Group} and Kameshwar Prasad and Alka Sharma and Ajay Garg and Sujata Mohanty and Shinjini Bhatnagar and Sharat Johri and Singh, {Kunwar Karni} and Velu Nair and Sarkar, {Ravi Shankar} and Gorthi, {Sankar Prasad} and Hassan, {Kaukab Maqbool} and Sudesh Prabhakar and Neelam Marwaha and Niranjan Khandelwal and Misra, {Usha Kant} and Jayantee Kalita and Soniya Nityanand",
year = "2014",
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language = "English",
volume = "45",
pages = "3618--3624",
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issn = "0039-2499",
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}

Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke : A multicentric, randomized trial. / InveST Study Group.

In: Stroke, Vol. 45, No. 12, 01.01.2014, p. 3618-3624.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke

T2 - A multicentric, randomized trial

AU - InveST Study Group

AU - Prasad, Kameshwar

AU - Sharma, Alka

AU - Garg, Ajay

AU - Mohanty, Sujata

AU - Bhatnagar, Shinjini

AU - Johri, Sharat

AU - Singh, Kunwar Karni

AU - Nair, Velu

AU - Sarkar, Ravi Shankar

AU - Gorthi, Sankar Prasad

AU - Hassan, Kaukab Maqbool

AU - Prabhakar, Sudesh

AU - Marwaha, Neelam

AU - Khandelwal, Niranjan

AU - Misra, Usha Kant

AU - Kalita, Jayantee

AU - Nityanand, Soniya

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background and Purpose - Pilot 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.Methods - This 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 18fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days.Results - Fifty-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 18fluorodeoxyglucose uptake.Conclusions - With 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.

AB - Background and Purpose - Pilot 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.Methods - This 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 18fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days.Results - Fifty-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 18fluorodeoxyglucose uptake.Conclusions - With 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.

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U2 - 10.1161/STROKEAHA.114.007028

DO - 10.1161/STROKEAHA.114.007028

M3 - Article

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EP - 3624

JO - Stroke

JF - Stroke

SN - 0039-2499

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