Skip to main content
OpenTrials
Completed

NCT Number: NCT03080571

Intraarterial Stem Cells in Subacute Ischemic Stroke

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Infarction, Middle Cerebral Artery Intracranial Arterial Diseases Ischemia MCA Infarction Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous BMMNC stem cells

Biological

Autologous BMMNC injected in the ipsilateral MCA

Standard care

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2017
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.