MedDataX Logo

Mesenchymal Stem Cells in Central Nervous System injury2017

NCT ID: NCT03291366

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MSC

infusion of aUCMSC and conventional therapy

Group Type EXPERIMENTAL

UCMSCC

Intervention Type DRUG

infusion of aUCMSC and conventional therapy

conventional treatment

Intervention Type DRUG

conventional treatment

conventional

conventional therapy

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type DRUG

conventional treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UCMSCC

infusion of aUCMSC and conventional therapy

Intervention Type DRUG

conventional treatment

conventional treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianming Tan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSC-CNS2017

Identifier Type: -

Identifier Source: org_study_id