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

History of Changes

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 (Adult)
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


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:


Wounds and Injuries Trauma, Nervous System Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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