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

April 17, 2017 updated by: Chen shuangfeng, Liaocheng People's Hospital
The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Liaocheng, Shandong, China, 0635
        • Recruiting
        • Liaocheng city people's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The patients were treated by human cord blood mononuclear cell through subarachnoid space
Other: hyperbaric oxygen
The patients were treated by hyperbaric oxygen
Placebo Comparator: control group
hyperbaric oxygen
Other: hyperbaric oxygen
The patients were treated by hyperbaric oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Mini-Mental State Examination (MMSE)
Time Frame: Baseline, 4, 8, 12 and 24 weeks
Baseline, 4, 8, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Chang from baseline in head CT
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months
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
Baseline, 1 and 2 months
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
Baseline,1 and 2 months
Change From Baseline in Activities of Daily Living (ADL)
Time Frame: Baseline, 4, 8, 12 and 24 weeks
Baseline, 4, 8, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaocheng People's Hospital

Investigators

  • Study Director: Shuangfeng Chen, Ph.D., Liaocheng People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 2, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cell therapy for neurology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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