Mesenchymal Stem Cells in Central Nervous System Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT01719640
First received: October 6, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 1y ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01719640

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

No publications provided

Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT01719640     History of Changes
Other Study ID Numbers: MSC-CNS
Study First Received: October 6, 2012
Last Updated: October 30, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Trauma, Nervous System
Wounds and Injuries
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014