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

February 6, 2024 updated by: Francisco Moniche, Andalusian Initiative for Advanced Therapies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Seville, Spain, 41013
        • Hospitales Universitarios Virgen del Rocío
      • Seville, Spain, 41071
        • Hospitales Universitarios Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Bone marrow transplantation low dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
Drug: Autologous bone marrow mononuclear cell intra-arterial injection
Experimental: Bone marrow transplantation high dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
Drug: Autologous bone marrow mononuclear cell intra-arterial injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 6 months
Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 24 months
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes
Time Frame: 6 months
Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months
6 months
Infarct volume
Time Frame: 6 months
Infarct volume change between baseline (DWI) and 6 months (FLAIR)
6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 24 months
24 months
Number of Participants with new-onset seizures as a Measure of Safety and Tolerability
Time Frame: 6 months
6 months
Functional outcomes
Time Frame: 6 months
Categorical shift in mRS ordinal (0-6) scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Initiative for Advanced Therapies

Investigators

  • Principal Investigator: Francisco Moniche, MD, PhD, Hospitales Universitarios Virgen del Rocío

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

April 12, 2023

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimated)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2013-002135-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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