Autologous Bone Marrow Stem Cells in Ischemic Stroke.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.

NCT00761982

Stroke, Acute Infarction, Middle Cerebral Artery

COMPLETED PHASE1/PHASE2

Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke

NCT01501773

Acute Stroke

COMPLETED PHASE2

Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

NCT01028794

Cerebral Embolism Stroke

COMPLETED PHASE1/PHASE2

Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

NCT00859014

Ischemic Stroke

COMPLETED PHASE1

Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

NCT02065778

Cerebrovascular Accident

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed trial will involve the recruitment of a total of 10 patients.

The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.

Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.

Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Infarction, Middle Cerebral Artery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CD34+ stem/progenitor cell therapy

Patients presenting within 7 days of onset with severe anterior circulation ischemic stroke (National Institutes of Health Stroke Scale \[NIHSS\] score≥8). CD34+ cells were collected from the bone marrow of the subjects before being delivered by catheter angiography into the ipsilesional middle cerebral artery.

Group Type EXPERIMENTAL

Infusion of autologous CD34+ stem cells into middle cerebral artery

Intervention Type BIOLOGICAL

intra-arterial infusion into ipsilateral MCA, via trans-femoral approach

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infusion of autologous CD34+ stem cells into middle cerebral artery

intra-arterial infusion into ipsilateral MCA, via trans-femoral approach

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptoms and signs of clinically definite acute stroke
* Time of stroke onset is known and treatment can be started within 7 days of onset
* CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
* The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
* An age range of 30-80 years old
* Stroke confined to MCA territory on CT or MRI brain imaging
* NIHSS score \>/= 8

Exclusion Criteria

* Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
* Haematological causes of stroke
* Severe co-morbidity
* Hepatic or renal dysfunction
* The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
* Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is \< 3.0 or \> 20.0mmol/L
* Patient is likely to be unavailable for follow-up e.g. no fixed home address
* Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
* Patient was already dependent in activities of daily living before the present acute stroke
* Patients who have been included in any other clinical trial within the previous month

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No