Original Query: "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"
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Intraarterial Stem Cells in Subacute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03080571
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Vikas Bhatia, Postgraduate Institute of Medical Education and Research

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke MCA Infarction Biological: autologous BMMNC stem cells Other: standard care Phase 1

Detailed Description:
  1. 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.
  2. 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.
  3. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group.
  4. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: test group :Stem cell plus standard care control group : standard care
Masking: Single (Outcomes Assessor)
Masking Description: PROBE design
Primary Purpose: Treatment
Official Title: To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients
Actual Study Start Date : July 2015
Primary Completion Date : December 2016
Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Stem cell group
autologous BMMNC stem cells with standard care
Biological: autologous BMMNC stem cells
Autologous BMMNC injected in the ipsilateral MCA
Other: standard care
Active Comparator: Control
Patients randomised in this group received standard care only
Other: standard care

Primary Outcome Measures :
  1. Change in National Institutes of Health Stroke Scale [ Time Frame: 6 month ]
    increase in National Institutes of Health Stroke Scale more than / equal to 4 points

  2. symptomatic intracranial hemorrhage [ Time Frame: 6 month ]
  3. new ischemic lesion [ Time Frame: 6 month ]
  4. Death [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. modified rankin score [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03080571

Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Study Director: Vivek Gupta, DM Postgraduate Institute of Medical Education and Research
Principal Investigator: Vikas Bhatia, DM Postgraduate Institute of Medical Education and Research


Responsible Party: Vikas Bhatia, Principal investigator, Postgraduate Institute of Medical Education and Research Identifier: NCT03080571     History of Changes
Other Study ID Numbers: PGIMER RADIOLOGY
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Cerebral Infarction
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Intracranial Arterial Diseases