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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02952716

Enrollment

Registered

2016-11-02

Start date

2016-10-31

Completion date

2019-12-31

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Encephalopathy After Carbon Monoxide Poisoning

Keywords

carbon monoxide poisoning, delayed encephalopathy

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

Interventions

BIOLOGICALHuman cord blood mononuclear cell

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

OTHERhyperbaric oxygen

The patients were treated by hyperbaric oxygen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 60 Years

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Contacts

Primary ContactShaoda Ren, Ph.D.

zslrsd@163.com86-0635-8272202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026