search
Back to results

Intraarterial Stem Cells in Subacute Ischemic Stroke

Primary Purpose

Ischemic Stroke, MCA Infarction

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
autologous BMMNC stem cells
standard care
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Requires presence of all of the following

  1. Age range 20-80 years symptoms
  2. Signs of clinically definite MCA stroke (0 to 14 days post ictus)
  3. National Institute of Health Stroke Scale (NIHSS)> 7,
  4. Stroke clinically and on imaging conforming to the MCA territory,
  5. Recanalization/patency of involved M1 segment of MCA on imaging
  6. Patency of carotid arteries for intra-arterial access of cerebral circulation

Exclusion Criteria: Requires presence of any of the following

  1. cerebral hemorrhage on CT/MRI
  2. Imaging evidence of M1-MCA segment complete occlusion
  3. Hemodynamic instability
  4. Known defect of clotting or platelet function
  5. Severe co-morbidity precluding intra-arterial intervention
  6. Hepatic or renal dysfunction
  7. Pregnant patients
  8. Patient likely to be unavailable for follow-up
  9. Patients with evidence of chronic illness or advanced cancer
  10. Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS >3
  11. Refusal to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stem cell group

    Control

    Arm Description

    autologous BMMNC stem cells with standard care

    Patients randomised in this group received standard care only

    Outcomes

    Primary Outcome Measures

    Change in National Institutes of Health Stroke Scale
    increase in National Institutes of Health Stroke Scale more than / equal to 4 points
    symptomatic intracranial hemorrhage
    new ischemic lesion
    Death

    Secondary Outcome Measures

    modified rankin score
    A modified rankin score of 0-1 in patients with National Institutes of Health Stroke Scale of 8-14 at the admission and modified rankin score of 0-2 in patients with National Institutes of Health Stroke Scale >14 at the admission.

    Full Information

    First Posted
    March 7, 2017
    Last Updated
    March 14, 2017
    Sponsor
    Postgraduate Institute of Medical Education and Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03080571
    Brief Title
    Intraarterial Stem Cells in Subacute Ischemic Stroke
    Official Title
    To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Medical Education and Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible damage to neurons and glial cells, leading to functional deficits and chronic sequelae with variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis. We conducted a prospective randomised end observer blinded study to evaluate primarily the safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate the outcome on the basis of clinical evaluation and follow up imaging
    Detailed Description
    This study was done over a period of one and a half years from July 2015 to December 2016. A total of 229 patients who presented with acute middle cerebral artery stroke and admitted at Post graduate institute of medical education and research were evaluated for recruitment into this study. Participants who satisfied the inclusion criteria were randomized at 1 week into control and stem cell infusion test group within 15 days of stroke onset. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group. Participants in the test group were infused autologous bone marrow mononuclear cells through intraarterial route using a microcatheter which was placed in proximal ipsilateral M1 segment of MCA. Participants in the control group did not receive stem cell therapy. Rest of the pharmacological treatment and physiotherapy were similar in both groups for the period of 6 months. 5,Participants were evaluated with clinical and radiological follow up at 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, MCA Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    test group :Stem cell plus standard care control group : standard care
    Masking
    Outcomes Assessor
    Masking Description
    PROBE design
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stem cell group
    Arm Type
    Experimental
    Arm Description
    autologous BMMNC stem cells with standard care
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients randomised in this group received standard care only
    Intervention Type
    Biological
    Intervention Name(s)
    autologous BMMNC stem cells
    Intervention Description
    Autologous BMMNC injected in the ipsilateral MCA
    Intervention Type
    Other
    Intervention Name(s)
    standard care
    Primary Outcome Measure Information:
    Title
    Change in National Institutes of Health Stroke Scale
    Description
    increase in National Institutes of Health Stroke Scale more than / equal to 4 points
    Time Frame
    6 month
    Title
    symptomatic intracranial hemorrhage
    Time Frame
    6 month
    Title
    new ischemic lesion
    Time Frame
    6 month
    Title
    Death
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    modified rankin score
    Description
    A modified rankin score of 0-1 in patients with National Institutes of Health Stroke Scale of 8-14 at the admission and modified rankin score of 0-2 in patients with National Institutes of Health Stroke Scale >14 at the admission.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Requires presence of all of the following Age range 20-80 years symptoms Signs of clinically definite MCA stroke (0 to 14 days post ictus) National Institute of Health Stroke Scale (NIHSS)> 7, Stroke clinically and on imaging conforming to the MCA territory, Recanalization/patency of involved M1 segment of MCA on imaging Patency of carotid arteries for intra-arterial access of cerebral circulation Exclusion Criteria: Requires presence of any of the following cerebral hemorrhage on CT/MRI Imaging evidence of M1-MCA segment complete occlusion Hemodynamic instability Known defect of clotting or platelet function Severe co-morbidity precluding intra-arterial intervention Hepatic or renal dysfunction Pregnant patients Patient likely to be unavailable for follow-up Patients with evidence of chronic illness or advanced cancer Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS >3 Refusal to give informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vivek Gupta, DM
    Organizational Affiliation
    Postgraduate Institute of Medical Education and Research
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Vikas Bhatia, DM
    Organizational Affiliation
    Postgraduate Institute of Medical Education and Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22764211
    Citation
    Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.
    Results Reference
    background
    PubMed Identifier
    21175286
    Citation
    Battistella V, de Freitas GR, da Fonseca LM, Mercante D, Gutfilen B, Goldenberg RC, Dias JV, Kasai-Brunswick TH, Wajnberg E, Rosado-de-Castro PH, Alves-Leon SV, Mendez-Otero R, Andre C. Safety of autologous bone marrow mononuclear cell transplantation in patients with nonacute ischemic stroke. Regen Med. 2011 Jan;6(1):45-52. doi: 10.2217/rme.10.97.
    Results Reference
    background
    PubMed Identifier
    19531871
    Citation
    Suarez-Monteagudo C, Hernandez-Ramirez P, Alvarez-Gonzalez L, Garcia-Maeso I, de la Cuetara-Bernal K, Castillo-Diaz L, Bringas-Vega ML, Martinez-Aching G, Morales-Chacon LM, Baez-Martin MM, Sanchez-Catasus C, Carballo-Barreda M, Rodriguez-Rojas R, Gomez-Fernandez L, Alberti-Amador E, Macias-Abraham C, Balea ED, Rosales LC, Del Valle Perez L, Ferrer BB, Gonzalez RM, Bergado JA. Autologous bone marrow stem cell neurotransplantation in stroke patients. An open study. Restor Neurol Neurosci. 2009;27(3):151-61. doi: 10.3233/RNN-2009-0483.
    Results Reference
    background
    PubMed Identifier
    21786299
    Citation
    Savitz SI, Misra V, Kasam M, Juneja H, Cox CS Jr, Alderman S, Aisiku I, Kar S, Gee A, Grotta JC. Intravenous autologous bone marrow mononuclear cells for ischemic stroke. Ann Neurol. 2011 Jul;70(1):59-69. doi: 10.1002/ana.22458.
    Results Reference
    background
    PubMed Identifier
    22507676
    Citation
    Friedrich MA, Martins MP, Araujo MD, Klamt C, Vedolin L, Garicochea B, Raupp EF, Sartori El Ammar J, Machado DC, Costa JC, Nogueira RG, Rosado-de-Castro PH, Mendez-Otero R, Freitas GR. Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant. 2012;21 Suppl 1:S13-21. doi: 10.3727/096368912x612512.
    Results Reference
    background

    Learn more about this trial

    Intraarterial Stem Cells in Subacute Ischemic Stroke

    We'll reach out to this number within 24 hrs