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this record recently (last verified Sep 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2017, registered Sep 2017).
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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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.

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Conditions studied

  • Central Nervous System Injury

Browse trials for

03

In context

Trauma, Nervous System

80 studies on the registry are indexed under Trauma, Nervous System; 23 are open to participants now.

This study's planned enrollment of 30 is below the median of 41 across 58 interventional studies indexed under Trauma, Nervous System.

Browse Trauma, Nervous System studies →

Lead sponsor

Fuzhou General Hospital is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
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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

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What researchers measure

Primary outcomes

  1. life quality score

    Time frame: 1y

Secondary outcomes

  1. adverse events

    Time frame: 1y

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2017 (actual). Primary completion is estimated for Jan 2020, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Jan 2017
Primary completionEst.
Jan 2020
CompletionEst.
Jan 2022
Last update
Sep 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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