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

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ClinicalTrials.gov Identifier: NCT02952716
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chen shuangfeng, Liaocheng People's Hospital

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

Condition or disease Intervention/treatment Phase
Delayed Encephalopathy After Carbon Monoxide Poisoning Biological: Human cord blood mononuclear cell Other: hyperbaric oxygen Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change From Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 4, 8, 12 and 24 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952716


Contacts
Contact: Shaoda Ren, Ph.D. 86-0635-8272202 zslrsd@163.com

Locations
China, Shandong
Liaocheng city people's hospital Recruiting
Liaocheng, Shandong, China, 0635
Contact: Shaoda Ren, Ph.D.    86-0635-8272202    zslrsd@163.com   
Sponsors and Collaborators
Liaocheng People's Hospital
Investigators
Study Director: Shuangfeng Chen, Ph.D. Liaocheng People's Hospital

Responsible Party: Chen shuangfeng, Central Laboratory Director, Liaocheng People's Hospital
ClinicalTrials.gov Identifier: NCT02952716     History of Changes
Other Study ID Numbers: cell therapy for neurology
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chen shuangfeng, Liaocheng People's Hospital:
carbon monoxide poisoning
delayed encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Poisoning
Carbon Monoxide Poisoning
Central Nervous System Diseases
Nervous System Diseases
Chemically-Induced Disorders
Gas Poisoning
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs