prolonged disorders of consciousness
Conditions
Interventions
Experimental group:Intravenous infusion of umbilical cord mononuclear cells and conventional rehabilitation treatment.
Control group:Intravenous infusion of physiological saline and conventional rehabilitation treatment.
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Patients with prolonged consciousness disorders who have lost consciousness for more than 28 days after severe brain injury. 2) Gender is not restricted, age between 1-18 years old. 3) Patients have stable vital signs, without any major comorbidities or active infections. Liver and kidney function is normal: SGPT = 3 times the upper limit of normal, ALT, AST = 2.5 times the upper limit of normal, serum Cr and BUN = 1.25 times the upper limit of normal. No significant abnormalities in electrocardiogram, and no new appearance of pneumonia in pulmonary imaging examination. 4) Informed consent form can be signed by the patient's guardian, provided that they have been fully informed of the situation.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrolled intracranial infection during the study period or requiring reoperation on the brain. 2) Patients with uncontrolled active infections, or those who are HIV-positive, hepatitis B or hepatitis C positive, or syphilis positive. 3) Patients with abnormal immune function screening or a history of allergic reactions. 4) Patients who are currently participating in other clinical trials. 5) Patients whose guardians or close relatives strongly oppose their participation in the clinical study. 6) Patients deemed unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| electroencephalogram, EEG;the coma recovery scale-revised, CRS-R/CRS-P;Persistent Vegetative State Clinical Efficacy Assessment Scale;auditory evoked potential, ABR;visual evoked potential, FVEP;brain magnetic resonance imaging, MRI;arterial spin labeling, ASL;diffusion tensor imaging, DTI; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs;routine blood test and liver and kidney function; | — |
Countries
China
Contacts
Public ContactZhu Dengna
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed