Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke
3 other identifiers
interventional
12
1 country
1
Brief Summary
This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 10, 2007
CompletedFirst Posted
Study publicly available on registry
May 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 19, 2011
May 1, 2011
5.4 years
May 10, 2007
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.
4 months
Secondary Outcomes (2)
Improvement of neurological deficits
4 months
Improvement in the neuroimaging exams
4 months
Interventions
Intra-arterial or intravenous delivery of autologous bone marrow cells
Eligibility Criteria
You may qualify if:
- clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset
- neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory
- age between 18 and 75 years old
- NIHSS between 4 and 20
- spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI
- signed informed consent
You may not qualify if:
- difficult in obtaining vascular access for percutaneous procedures
- vascular impossibility to reach the middle cerebral artery through percutaneous approach
- severe carotid stenosis( \>70%, by Doppler) related to the severe stroke
- neurological worsening (\>4 points in the NIHSS ) due to edema or intracerebral hemorrhage
- primary hematological disease
- neurodegenerative disorder
- previous stroke with mRS \> 2
- intracardiac thrombosis
- auto-imune disorders
- osteopathies that could increase the risk of bone marrow harvesting procedure
- thrombophilias
- liver failure
- chronic renal failure (creatinine \> 2mg/ml)
- life support dependence
- lacunar stroke
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal do Rio de Janeirolead
- Ministry of Science and Technology, Brazilcollaborator
- Ministry of Health, Brazilcollaborator
- National Research Council, Brazilcollaborator
Study Sites (1)
Hospital Universitário Clementino Fraga Filho/UFRJ
Rio de Janeiro, Rio de Janeiro, 21.941-590, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles André, MD, PhD
Universidade Federal do Rio de Janeiro
- PRINCIPAL INVESTIGATOR
Gabriel R de Freitas, MD, PhD
Universidade Federal do Rio de Janeiro
- PRINCIPAL INVESTIGATOR
Rosalia Mendez-Otero, Md, PhD
Universidade Federal do Rio de Janeiro
- PRINCIPAL INVESTIGATOR
Lea Mirian Barbosa da Fonseca, MD, PhD
Universidade Federal do Rio de Janeiro
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2007
First Posted
May 14, 2007
Study Start
December 1, 2005
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 19, 2011
Record last verified: 2011-05