NCT00761982

Brief Summary

The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

2.9 years

First QC Date

September 28, 2008

Last Update Submit

November 27, 2011

Conditions

Stroke, AcuteInfarction, Middle Cerebral Artery

Outcome Measures

Primary Outcomes (1)

  • Absence of new neurological deficits and adverse effects during the timeframe.

    Duration of study

Secondary Outcomes (1)

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

    Duration of study

Study Arms (1)

bone marrow stem cells

OTHER

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

Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery

Interventions

Infusion on autologous CD34+ stem cells into middle cerebral arteryPROCEDURE

Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients

bone marrow stem cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms and signs of clinically definite middle cerebral artery acute stroke.
  • Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
  • DWI-MRI has reliably shown relevant acute ischemic lesions
  • Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
  • The stroke is severe (NIH Stroke Scale \>= 8 before procedure).
  • An age range of 18-80 years old.

You may not qualify if:

  • Lacunar infarction.
  • Patients with cancer.
  • Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
  • Hematological 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.
  • Patient is likely to be unavailable for follow-up.
  • Patient with evidence of life threatening infection of life threatening illness.
  • Patient was already dependent in activities of daily living before the present acute stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospitales Universitarios Virgen del Rocío

Seville, Andalusia, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Publications (2)

  • Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.

    PMID: 22764211DERIVED

  • 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: 22163120DERIVED

MeSH Terms

Conditions

StrokeInfarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral InfarctionBrain InfarctionBrain IschemiaCerebral Arterial DiseasesIntracranial Arterial DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2008

First Posted

September 30, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

ES(2)