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Mesenchymal Stem Cells in Central Nervous System Injury

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Fuzhou General Hospital Identifier:
First received: October 6, 2012
Last updated: October 30, 2012
Last verified: October 2012
Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.

Condition Intervention Phase
Central Nervous System Injury Biological: infusion of MSCs Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System Injury

Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • life quality score [ Time Frame: 1y ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 1y ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSC
infusion of MSCs at day 0, 7, 14, 21
Biological: infusion of MSCs


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CNS injury > 3 months
  • age > 18 years
  • willing to give consent

Exclusion Criteria:

  • any contradiction to intrathecal infusion
  • age < 18 years
  • CNS injury < 3 months
  • CNS injury > 3 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01719640

China, Fujian
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
  More Information

Responsible Party: Fuzhou General Hospital Identifier: NCT01719640     History of Changes
Other Study ID Numbers: MSC-CNS
Study First Received: October 6, 2012
Last Updated: October 30, 2012

Keywords provided by Fuzhou General Hospital:
mesenchymal stem cell
central nervous system

Additional relevant MeSH terms:
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases processed this record on July 24, 2017