search
Back to results

Autologous Bone Marrow Stem Cells in Ischemic Stroke.

Primary Purpose

Stroke, Acute, Infarction, Middle Cerebral Artery

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Infusion of autologous CD34+ stem cells into middle cerebral artery
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke, Acute focused on measuring Stroke, Middle Cerebral Artery

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Marys Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD34+ stem/progenitor cell therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results

Secondary Outcome Measures

Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.

Full Information

First Posted
September 25, 2007
Last Updated
July 4, 2019
Sponsor
Imperial College London
search

1. Study Identification

Unique Protocol Identification Number
NCT00535197
Brief Title
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
Official Title
A Phase I/II Safety and Tolerability Study Following the Autologous Infusion of Immuno-selected CD34+ Subset Bone Marrow Stem Cells Into Patients With Acute Total Anterior Circulation Ischaemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Infarction, Middle Cerebral Artery
Keywords
Stroke, Middle Cerebral Artery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD34+ stem/progenitor cell therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Infusion of autologous CD34+ stem cells into middle cerebral artery
Intervention Description
intra-arterial infusion into ipsilateral MCA, via trans-femoral approach
Primary Outcome Measure Information:
Title
Safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Description
safety will be evaluated in terms of adverse events graded according to CTC toxicity criteria and laboratory test results
Time Frame
Duration of study
Secondary Outcome Measure Information:
Title
Improvement in clinical function as assessed by the Modified Rankin Score, and NIH stroke scale.
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagy Habib, Professor
Organizational Affiliation
Imperial College London U.K.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Marys Hospital
City
Paddington
State/Province
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25107583
Citation
Banerjee S, Bentley P, Hamady M, Marley S, Davis J, Shlebak A, Nicholls J, Williamson DA, Jensen SL, Gordon M, Habib N, Chataway J. Intra-Arterial Immunoselected CD34+ Stem Cells for Acute Ischemic Stroke. Stem Cells Transl Med. 2014 Nov;3(11):1322-30. doi: 10.5966/sctm.2013-0178. Epub 2014 Aug 8.
Results Reference
result
PubMed Identifier
22163120
Citation
Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
Results Reference
derived

Learn more about this trial

Autologous Bone Marrow Stem Cells in Ischemic Stroke.

We'll reach out to this number within 24 hrs