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Completed

NCT Number: NCT02178657

Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Puerta del Mar, Cadiz, Spain

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About this study

This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with middle cerebral artery (MCA) acute ischemic stroke.
  • Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
  • DWI-MRI has reliably shown acute MCA ischemic lesions
  • Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability
  • National Institute of Health Stroke Scale score of 6-20 at inclusion
  • Age 18-80 years
  • Written informed consent has been obtained

Exclusion criteria

  • Hemorrhagic stroke or symptomatic hemorrhagic transformation
  • Lacunar infarction
  • Preocclusive stenosis or total occlusion of ipsilateral carotid artery
  • Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema
  • Decrease of consciousness with a Glasgow Coma Scale of <8 points
  • Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
  • Contraindication for MRI or for bone marrow harvest
  • Previous diagnosis of neurodegenerative disease
  • Acute heart failure
  • Hepatic or renal dysfunction (creatinine >2mg/dL)
  • Coagulopathy
  • Severe co-morbidity
  • Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
  • Modified Rankin Score (mRS) before stroke of ≥2
  • Participation in any clinical trial in the last 3 months

Treatment and study plan

Autologous bone marrow mononuclear cell intra-arterial injection

Drug

Primary outcomes

  1. Disability

    Time frame: 6 months

    Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months

Secondary outcomes

  1. Mortality

    Time frame: 24 months

Other outcomes

  1. Functional outcomes

    Time frame: 6 months

    Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months

  2. Infarct volume

    Time frame: 6 months

    Infarct volume change between baseline (DWI) and 6 months (FLAIR)

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 months

  4. Number of Participants with new-onset seizures as a Measure of Safety and Tolerability

    Time frame: 6 months

  5. Functional outcomes

    Time frame: 6 months

    Categorical shift in mRS ordinal (0-6) scale

Sponsors and collaborators

Lead sponsor

Andalusian Initiative for Advanced Therapies

Other Gov

Registry information

Official study title

Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.

Important dates

Study start
2015
Primary completion
2021
Study completion
2023
First posted
Jul 1, 2014
Registry last updated
Feb 7, 2024

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.

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