Acute Lung InjuryPhase 1/2NCT02095444
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
A Phase 1/2 study testing Menstrual blood stem cells in people with Acute Lung Injury and Acute Respiratory Distress Syndrome (ARDS), run by S-Evans Biosciences Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure
- What is being tested?
- Menstrual blood stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of H7N9 infection
- must be critical injured for lung tissues
Who cannot join
- cancer diseases
- pregnancy
- mental disorder
- allergic constitution
- severe inflammation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital
Hangzhou, Zhejiang, 310003
Charlie Xiang, Doctor, 86-571-87236426, cxiang@zju.edu.cn
About this study
Official title: Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
The purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.
Read the detailed description
- recruiting volunteers of H7N9 infection: age > 18; patients signed with the informed consent; APACHE II > 20 score
- patients infused with menstrual blood progenitor cells infusion dose: 1~10×10*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion
- test items and standard spirits lifted; pulmonary function improved; lung image injury improved
- Being tested
- Menstrual blood stem cells
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual blood stem cellsDrug
10*7 cells/kg, intravenous injection for 4 times during two weeks
| Study group | Role | What they receive |
|---|---|---|
| Menstrual blood stem cells | Experimental | 1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks. Receives: Drug: Menstrual blood stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of lung injury
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S-Evans Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Charlie Xiang, Doctor, Principal investigator, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095444
- Sponsor's protocol ID
- SEB-2014-2-20
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
- ClinicalTrials.gov ID
- NCT02095444
- Acronym / sponsor ID
- SEB-2014-2-20
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- S-Evans Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Mar 2014 (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 purpose of this study is to determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus caused acute lung injury.
Detailed description
- recruiting volunteers of H7N9 infection: age > 18; patients signed with the informed consent; APACHE II > 20 score
- patients infused with menstrual blood progenitor cells infusion dose: 1~10×10*7 cells/kg infusion frequency: 2 times a week, 2 weeks for infusion
- test items and standard spirits lifted; pulmonary function improved; lung image injury improved
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menstrual blood stem cells | Experimental | Drug: Menstrual blood stem cells1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of H7N9 infection
- must be critical injured for lung tissues
Key exclusion criteria (5 listed)
- cancer diseases
- pregnancy
- mental disorder
- allergic constitution
- severe inflammation
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 |
|---|---|---|
| Menstrual blood stem cells10*7 cells/kg, intravenous injection for 4 times during two weeks | Drug | Menstrual blood stem cells |
Primary outcome
The degree of lung injury
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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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.
Charlie Xiang, Doctor principal investigator
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University
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 Menstrual blood stem cells in people with Acute Lung Injury and Acute Respiratory Distress Syndrome (ARDS), run by S-Evans Biosciences Co., Ltd. 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 2 inclusion and 5 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 24 Mar 2014. 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. 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 Charle Xiang, Doctor (86-571-87236426, cxiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of lung injury (time frame: 14 days). 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 24 Mar 2014.