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

Phase 1

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome (ARDS); Multiple Organ Failure
• Interventions: Drug: Menstrual blood stem cells

• Registration Number: NCT02095444
• Lead Sponsor: S-Evans Biosciences Co., Ltd.

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

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

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Menstrual blood stem cells	Menstrual blood stem cells	1x10\*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.

Primary Outcome Measures

Name	Time	Method
The degree of lung injury	14 days

Trial Locations

Locations (1)

State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital; 🇨🇳 Hangzhou, Zhejiang, China