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

NCT ID: NCT02952716

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

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

Conditions

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Delayed Encephalopathy After Carbon Monoxide Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Human cord blood mononuclear cell

Intervention Type BIOLOGICAL

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

hyperbaric oxygen

Intervention Type OTHER

The patients were treated by hyperbaric oxygen

control group

hyperbaric oxygen

Group Type PLACEBO_COMPARATOR

hyperbaric oxygen

Intervention Type OTHER

The patients were treated by hyperbaric oxygen

Interventions

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Human cord blood mononuclear cell

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

Intervention Type BIOLOGICAL

hyperbaric oxygen

The patients were treated by hyperbaric oxygen

Intervention Type OTHER

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liaocheng People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen shuangfeng

Central Laboratory Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuangfeng Chen, Ph.D.

Role: STUDY_DIRECTOR

Liaocheng People's Hospital

Locations

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Liaocheng city people's hospital

Liaocheng, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shaoda Ren, Ph.D.

Role: CONTACT

86-0635-8272202

Facility Contacts

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Shaoda Ren, Ph.D.

Role: primary

86-0635-8272202

Other Identifiers

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cell therapy for neurology

Identifier Type: -

Identifier Source: org_study_id

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