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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952716
Recruitment Status : Unknown
Verified April 2017 by Chen shuangfeng, Liaocheng People's Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chen shuangfeng, Liaocheng People's Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Change From Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 4, 8, 12 and 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02952716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • Chang from baseline in head CT [ Time Frame: 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 ]
  • 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 ]
  • Change From Baseline in Activities of Daily Living (ADL) [ Time Frame: Baseline, 4, 8, 12 and 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • Chang from baseline in head CT [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline,1 and 2 months ]
  • Change From Baseline in Activities of Daily Living (ADL) [ Time Frame: Baseline, 4, 8, 12 and 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
Official Title  ICMJE Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Delayed Encephalopathy After Carbon Monoxide Poisoning
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: intervention group
    Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days.
    Interventions:
    • Biological: Human cord blood mononuclear cell
    • Other: hyperbaric oxygen
  • Placebo Comparator: control group
    hyperbaric oxygen
    Intervention: Other: hyperbaric oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
100
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952716
Other Study ID Numbers  ICMJE cell therapy for neurology
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chen shuangfeng, Liaocheng People's Hospital
Study Sponsor  ICMJE Liaocheng People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shuangfeng Chen, Ph.D. Liaocheng People's Hospital
PRS Account Liaocheng People's Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP