CClinicalTrials.gg
Sign In
Status unknownNCT02952716Updated Apr 18, 2017

Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning

A Phase 1/2 interventional study of Human cord blood mononuclear cell and hyperbaric oxygen in Delayed Encephalopathy After Carbon Monoxide Poisoning, sponsored by Liaocheng People's Hospital. Status unknown at 1 site in China. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by Liaocheng People's Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning

Read the detailed description

To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning

02

Conditions studied

  • Delayed Encephalopathy After Carbon Monoxide Poisoning

Keywords

  • carbon monoxide poisoning
  • delayed encephalopathy
03

In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 454 interventional studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Liaocheng People's Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 35-60 years old.
  • No serious infection, chronic diseases, diabetes and tuberculosis.
  • Written informed consents were obtained from all subjects.
  • Symptomatic Delayed Encephalopathy After Carbon Monoxide Poisoning.

Exclusion criteria

Exclusion Criteria:

  • The heart, liver, kidney and other viscera serious organic disease.
  • Allergic constitution, clotting disorders, autoimmune diseases and tumors.
  • Pregnancy.
  • Moribund patient.
  • History of prior brain injury.
  • History of central nervous system disease.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    intervention group

    Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days.

    Biological: Human cord blood mononuclear cell · Other: hyperbaric oxygen

  • Placebo comparator
    control group

    hyperbaric oxygen

    Other: hyperbaric oxygen

Interventions

  • BiologicalHuman cord blood mononuclear cell

    The patients were treated by human cord blood mononuclear cell through subarachnoid space

  • Otherhyperbaric oxygen

    The patients were treated by hyperbaric oxygen

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mini-Mental State Examination (MMSE)

    Time frame: Baseline, 4, 8, 12 and 24 weeks

Secondary outcomes

  1. Chang from baseline in head CT

    Time frame: Baseline, 6 and 12 months

  2. Cerebrospinal levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)

    Time frame: Baseline, 1 and 2 months

  3. Serum levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ，IL-17A，IL-8，IL-12p70，MIG，MCP-1(ng/ul)

    Time frame: Baseline,1 and 2 months

  4. Change From Baseline in Activities of Daily Living (ADL)

    Time frame: Baseline, 4, 8, 12 and 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Liaocheng city people's hospital
    Liaocheng, Shandong 0635, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952716
Lead sponsor
Liaocheng People's Hospital
Responsible party
Chen shuangfeng (Central Laboratory Director, Liaocheng People's Hospital) — Principal investigator
First posted
Nov 2, 2016
Start date
Oct 2016
Primary completion
Oct 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Apr 18, 2017

Study contacts

Shaoda Ren, Ph.D.
Contact
zslrsd@163.com
86-0635-8272202
Shuangfeng Chen, Ph.D.
study director · Liaocheng People's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Diseases→

Other studies from this sponsor

Liaocheng People's Hospital

Start the discussion