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FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by China Medical University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01249287
First received: November 25, 2010
Last updated: November 26, 2010
Last verified: November 2010
History of Changes
  Purpose

A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. In this study, the investigators will test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination of corticospinal tract in the lesion side, focal increased perfusion and increased cortical activity in the peri-infarcted area will be monitored by the functional MRI after stem cell therapy. The investigators study is aimed to find the potential mechanisms of the functional recovery after stem cell implantation. The investigators also hope to find image surrogate markers for prediction of patient outcome. The possible surrogate markers will be helpful in improving the treatment procedure and patient selection.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 30
Study Start Date: April 2009
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University hospital

Criteria

Inclusion Criteria:

  • Old stroke half an year ~3 year
  • One-sided MCA infarction
  • NIHSS stroke scale: 9-20

Exclusion Criteria:

  • Pacemaker
  • Cerebral aneurysm clips
  • Neurostimulator
  • Metallic heart valves
  • IUD
  • Joint replacement
  • Metal plates
  • Bone or joint pins
  • Vena cava filters
  • Embolization coils
  • Cochlear implants
  • Greenfieid filer
  • Seizures
  • Claustrophobia
  • Bullet/gunshot
  • Prosthesis (non-removeable)
  • Artificial limbs (non-removeable)
  • Surgical slips
  • Metal screws or pins>
  • Shrapnel/metallic fragments
  • Harrington rod
  • Insulin pump
  • Ever had metal removed from in or around the eye
  • Ever been metal worker (i.e., welder, machinist)
  • Non-removeable hearing aids
  • Birdnest or Gianturco filter
  • Pregnant
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01249287     History of Changes
Other Study ID Numbers: DMR98-IRB-031
Study First Received: November 25, 2010
Last Updated: November 26, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University Hospital:
stroke
stem cell

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 21, 2013