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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

Tracking Information
First Submitted Date November 25, 2010
First Posted Date November 29, 2010
Last Update Posted Date November 29, 2010
Study Start Date April 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population University hospital
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November¬†26,¬†2010)
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sexes Eligible for Study: All
Ages 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT01249287
Other Study ID Numbers DMR98-IRB-031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party China Medical University Hospital
Study Sponsor China Medical University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account China Medical University Hospital
Verification Date November 2010