Delayed Encephalopathy After Carbon Monoxide PoisoningPhase 1/2NCT02952716
Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
A Phase 1/2 study testing Human cord blood mononuclear cell and hyperbaric oxygen in people with Delayed Encephalopathy After Carbon Monoxide Poisoning, run by Liaocheng People's Hospital at 1 site in China.
Trial summary
The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Delayed Encephalopathy After Carbon Monoxide Poisoning
- What is being tested?
- Human cord blood mononuclear cell and hyperbaric oxygen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaocheng city people's hospital
Liaocheng, Shandong, 0635
Shaoda Ren, Ph.D., 86-0635-8272202, zslrsd@163.com
About this study
The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning
Read the detailed description
To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning
- Being tested
- Human cord blood mononuclear cell, hyperbaric oxygen
- Keywords
- carbon monoxide poisoning, delayed encephalopathy
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human cord blood mononuclear cellBiological
The patients were treated by human cord blood mononuclear cell through subarachnoid space
hyperbaric oxygenOther
The patients were treated by hyperbaric oxygen
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Human Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days. Receives: Biological: Human cord blood mononuclear cell; Other: hyperbaric oxygen |
| control group | Placebo comparator | hyperbaric oxygen Receives: Other: hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mini-Mental State Examination (MMSE)
Measured: Baseline, 4, 8, 12 and 24 weeks
Secondary outcomes (4)
Chang from baseline in head CT
Measured: 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)
Measured: 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)
Measured: Baseline,1 and 2 months
Change From Baseline in Activities of Daily Living (ADL)
Measured: Baseline, 4, 8, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Encephalopathy After Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen shuangfeng, Liaocheng People's Hospital
- Investigators
- Shuangfeng Chen, Ph.D., Study director, Liaocheng People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952716
- Sponsor's protocol ID
- cell therapy for neurology
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT02952716
- Acronym / sponsor ID
- cell therapy for neurology
- Keywords
- carbon monoxide poisoning, delayed encephalopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Biological: Human cord blood mononuclear cell, Other: hyperbaric oxygenHuman Cord Blood Mononuclear Cell will be slowly infusion three times,at one days, 30 days,at 60days. |
| control group | Placebo comparator | Other: hyperbaric oxygenhyperbaric oxygen |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human cord blood mononuclear cellThe patients were treated by human cord blood mononuclear cell through subarachnoid space | Biological | intervention group |
| hyperbaric oxygenThe patients were treated by hyperbaric oxygen | Other | control group, intervention group |
Primary outcome
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame: Baseline, 4, 8, 12 and 24 weeks
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuangfeng Chen, Ph.D. study director
Liaocheng People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human cord blood mononuclear cell and hyperbaric oxygen in people with Delayed Encephalopathy After Carbon Monoxide Poisoning, run by Liaocheng People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaoda Ren, Ph.D. (86-0635-8272202, zslrsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mini-Mental State Examination (MMSE) (time frame: Baseline, 4, 8, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.