NCT03291366

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

September 20, 2017

Last Update Submit

September 20, 2017

Conditions

Central Nervous System Injury

Outcome Measures

Primary Outcomes (1)

  • life quality score

    1y

Secondary Outcomes (1)

  • adverse events

    1y

Study Arms (2)

MSC

EXPERIMENTAL

infusion of aUCMSC and conventional therapy

Drug: UCMSCCDrug: conventional treatment

conventional

ACTIVE COMPARATOR

conventional therapy

Drug: conventional treatment

Interventions

UCMSCCDRUG

infusion of aUCMSC and conventional therapy

MSC
conventional treatmentDRUG

conventional treatment

MSCconventional

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CNS injury \> 3 months
  • age \> 18 years
  • willing to give consent
  • stable vital signs
  • absence of active infectcion

You may not qualify if:

  • any contradiction to intrathecal infusion
  • age \< 18 years
  • CNS injury \< 3 months
  • CNS injury \> 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2022

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share