NCT01249287

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.

Trial Health

50
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
unknown

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

April 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
Last Updated

November 29, 2010

Status Verified

November 1, 2010

First QC Date

November 25, 2010

Last Update Submit

November 26, 2010

Conditions

Stroke

Keywords

strokestem cell

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University hospital

You may qualify if:

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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2010

First Posted

November 29, 2010

Study Start

April 1, 2009

Last Updated

November 29, 2010

Record last verified: 2010-11