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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02952716
Other study ID # cell therapy for neurology
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received October 2, 2016
Last updated April 17, 2017
Start date October 2016
Est. completion date December 2019

Study information

Verified date April 2017
Source Liaocheng People's Hospital
Contact Shaoda Ren, Ph.D.
Phone 86-0635-8272202
Email zslrsd@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2019
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Liaocheng city people's hospital Liaocheng Shandong

Sponsors (1)

Lead Sponsor Collaborator
Liaocheng People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Mini-Mental State Examination (MMSE) Baseline, 4, 8, 12 and 24 weeks
Secondary Chang from baseline in head CT Baseline, 6 and 12 months
Secondary Cerebrospinal levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-?,IL-17A,IL-8,IL-12p70,MIG,MCP-1(ng/ul) Baseline, 1 and 2 months
Secondary Serum levels of IL-2,IL-4,IL-6,IL-10,TNF,IFN-?,IL-17A,IL-8,IL-12p70,MIG,MCP-1(ng/ul) Baseline,1 and 2 months
Secondary Change From Baseline in Activities of Daily Living (ADL) Baseline, 4, 8, 12 and 24 weeks