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NCT02095444 Clinical Trial

Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection

Acute Lung Injury Clinical Trial

Official title:
Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02095444
Other study ID # SEB-2014-2-20
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received March 16, 2014
Last updated March 20, 2014
Start date March 2014
Est. completion date December 2016

Study information
Verified date March 2014
Source S-Evans Biosciences Co.,Ltd.
Contact Charle Xiang, Doctor
Phone 86-571-87236426
Email cxiang@zju.edu.cn
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Description:

1. recruiting volunteers of H7N9 infection: age > 18; patients signed with the informed consent; APACHE II > 20 score

2. 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

3. test items and standard spirits lifted; pulmonary function improved; lung image injury improved

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Menstrual blood stem cells
10*7 cells/kg, intravenous injection for 4 times during two weeks

Locations
Country Name City State
China State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital Hangzhou Zhejiang

Sponsors (2)
Lead Sponsor Collaborator
S-Evans Biosciences Co.,Ltd. First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The degree of lung injury 14 days Yes
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