A Phase I/II safety and tolerability study following autologous infusion of adult haematopoietic cells to patients with acute total anterior circulation ischaemic stroke

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000281-36-GB

Enrollment

Registered

2006-04-10

Start date

2007-05-11

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Total Anterior Circulation Ischaemic Stroke

Interventions

Product Name: Immuno-selected CD34+ haematopoietic stem cells Product Code: HHSC/003 Pharmaceutical Form: Suspension for injection Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Symptoms and signs of clinically definite acute stroke Time of onset is known & 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 total anterior circulation phenotype (weakness, homonymous hemianopia and focal cognitive deficit (e.g. aphasia) or reduction in consciousness. An age range of 30 to 80 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known defect of clotting or platelet function Haematological causes of stroke Severe co-morbidity Hepatic or renal dysfuction Patients with evidence of life-threatening infection (e.g. HIV) or life-threatening illness (e.g. advanced cancer) Patient should be excluded if blood glucose 20.0mmol/L Patient was already dependent in activities of daily living before the present stroke. Patients who have been included in any other clinical trial within the previous month Patients who are unavailable for follow-up (e.g. no fixed home address)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Determination of clinical improvement or deterioration by measurement of such parameters as performance scores (modified Rankin Scale and NIHS scale);Primary end point(s): No adverse effects directly attributable to the infused medicinal product;Main Objective: Safety and tolerability of infused immuno-selected CD34+ autologous adult haematopoietic stem cells	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026