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FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249287
Recruitment Status : Unknown
Verified November 2010 by China Medical University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2010
Last Update Posted : November 29, 2010
Information provided by:
China Medical University Hospital

Brief Summary:
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 or disease

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : April 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University hospital

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

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Responsible Party: China Medical University Hospital Identifier: NCT01249287     History of Changes
Other Study ID Numbers: DMR98-IRB-031
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: November 29, 2010
Last Verified: November 2010
Keywords provided by China Medical University Hospital:
stem cell
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases