Autologous Bone Marrow Stem Cells in Ischemic Stroke.

NCT00535197 | Completed Phase 1 DMC

• 1 other identifier: HHSC/003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke, Acute; Infarction, Middle Cerebral Artery

Keywords

Stroke; Middle Cerebral Artery

Outcome Measures

Primary Outcomes (1)

• 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

  Duration of study

Secondary Outcomes (1)

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

  Duration of study

Study Arms (1)

CD34+ stem/progenitor cell therapy

EXPERIMENTAL

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.

Biological: Infusion of autologous CD34+ stem cells into middle cerebral artery

Interventions

Infusion of autologous CD34+ stem cells into middle cerebral artery BIOLOGICAL

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

CD34+ stem/progenitor cell therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St Marys Hospital

Paddington, London, W2 1NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25107583 RESULT

• 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.

  PMID: 22163120 DERIVED

MeSH Terms

Conditions

Stroke; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nagy Habib, Professor

  Imperial College London U.K.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)