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

Primary Purpose

Delayed Encephalopathy After Carbon Monoxide Poisoning

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human cord blood mononuclear cell
hyperbaric oxygen
Sponsored by
Liaocheng People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Encephalopathy After Carbon Monoxide Poisoning focused on measuring carbon monoxide poisoning, delayed encephalopathy

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liaocheng city people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention group

control group

Arm Description

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

hyperbaric oxygen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Chang from baseline in head CT
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)
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)
Change From Baseline in Activities of Daily Living (ADL)

Full Information

First Posted
October 2, 2016
Last Updated
April 17, 2017
Sponsor
Liaocheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02952716
Brief Title
Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Official Title
Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaocheng People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning
Detailed Description
To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Encephalopathy After Carbon Monoxide Poisoning
Keywords
carbon monoxide poisoning, delayed encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
hyperbaric oxygen
Intervention Type
Biological
Intervention Name(s)
Human cord blood mononuclear cell
Intervention Description
The patients were treated by human cord blood mononuclear cell through subarachnoid space
Intervention Type
Other
Intervention Name(s)
hyperbaric oxygen
Intervention Description
The patients were treated by hyperbaric oxygen
Primary Outcome Measure Information:
Title
Change From Baseline in Mini-Mental State Examination (MMSE)
Time Frame
Baseline, 4, 8, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Chang from baseline in head CT
Time Frame
Baseline, 6 and 12 months
Title
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
Title
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
Title
Change From Baseline in Activities of Daily Living (ADL)
Time Frame
Baseline, 4, 8, 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoda Ren, Ph.D.
Phone
86-0635-8272202
Email
zslrsd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuangfeng Chen, Ph.D.
Organizational Affiliation
Liaocheng People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Liaocheng city people's hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
0635
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoda Ren, Ph.D.
Phone
86-0635-8272202
Email
zslrsd@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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