Status unknownNCT03291366Updated Sep 25, 2017

Mesenchymal Stem Cells in Central Nervous System injury2017

A Phase 1/2 interventional study of UCMSCC and conventional treatment in Central Nervous System Injury, sponsored by Fuzhou General Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Fuzhou General Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Central Nervous System Injury

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
MSC
infusion of aUCMSC and conventional therapy
Drug: UCMSCC · Drug: conventional treatment
Active comparator
conventional
conventional therapy
Drug: conventional treatment

Interventions

DrugUCMSCC
infusion of aUCMSC and conventional therapy
Drugconventional treatment
conventional treatment

What researchers measure

Primary outcomes

life quality score
Time frame: 1y

Secondary outcomes

adverse events
Time frame: 1y

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03291366
Lead sponsor: Fuzhou General Hospital
Responsible party: Jianming Tan (Professor, Fuzhou General Hospital) — Principal investigator
First posted: Sep 25, 2017
Start date: Jan 2017
Primary completion: Jan 2020 (estimated)
Completion: Jan 2022 (estimated)
Last update: Sep 25, 2017

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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