Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
Primary Purpose
Acute Lung Injury, Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Menstrual blood stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of H7N9 infection
- must be critical injured for lung tissues
Exclusion Criteria:
- cancer diseases
- pregnancy
- mental disorder
- allergic constitution
- severe inflammation
Sites / Locations
- State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Menstrual blood stem cells
Arm Description
1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.
Outcomes
Primary Outcome Measures
The degree of lung injury
Secondary Outcome Measures
Full Information
NCT ID
NCT02095444
First Posted
March 16, 2014
Last Updated
March 20, 2014
Sponsor
S-Evans Biosciences Co., Ltd.
Collaborators
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT02095444
Brief Title
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
Official Title
Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S-Evans Biosciences Co., Ltd.
Collaborators
First Affiliated Hospital of Zhejiang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Menstrual blood stem cells
Arm Type
Experimental
Arm Description
1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.
Intervention Type
Drug
Intervention Name(s)
Menstrual blood stem cells
Intervention Description
10*7 cells/kg, intravenous injection for 4 times during two weeks
Primary Outcome Measure Information:
Title
The degree of lung injury
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of H7N9 infection
must be critical injured for lung tissues
Exclusion Criteria:
cancer diseases
pregnancy
mental disorder
allergic constitution
severe inflammation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charle Xiang, Doctor
Phone
86-571-87236426
Email
cxiang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Xiang, Doctor
Organizational Affiliation
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Xiang, Doctor
Phone
86-571-87236426
Email
cxiang@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
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