Mesenchymal Stem Cells in Central Nervous System injury2017

Central Nervous System Injury Clinical Trial

Official title:

Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03291366
• Other study ID #: MSC-CNS2017
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 20, 2017
• Last updated: September 20, 2017
• Start date: January 2017
• Est. completion date: January 2022

Study information

• Verified date: September 2017
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• CNS injury > 3 months

• age > 18 years

• willing to give consent

• stable vital signs

• absence of active infectcion

Exclusion Criteria:

• any contradiction to intrathecal infusion

• age < 18 years

• CNS injury < 3 months

• CNS injury > 3 years

Related Conditions & MeSH terms

• Central Nervous System Injury
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Drug:
• UCMSCC
infusion of aUCMSC and conventional therapy
• conventional treatment
conventional treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	life quality score		1y
Secondary	adverse events		1y