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

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

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

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

Conditions
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Delayed Encephalopathy After Carbon Monoxide Poisoning

Intervention / Treatment
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* Biological: Human cord blood mononuclear cell
* Other: hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days. | Biological: Human cord blood mononuclear cell<br>* The patients were treated by human cord blood mononuclear cell through subarachnoid space<br>Other: hyperbaric oxygen<br>* The patients were treated by hyperbaric oxygen<br>|
| Placebo Comparator: control group<br>hyperbaric oxygen | Other: hyperbaric oxygen<br>* The patients were treated by hyperbaric oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon monoxide poisoning, delayed encephalopathy