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

NCT ID: NCT02095444

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Acute Lung Injury Acute Respiratory Distress Syndrome (ARDS) Multiple Organ Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Menstrual blood stem cells

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

Group Type EXPERIMENTAL

Menstrual blood stem cells

Intervention Type DRUG

10\*7 cells/kg, intravenous injection for 4 times during two weeks

Interventions

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Menstrual blood stem cells

10\*7 cells/kg, intravenous injection for 4 times during two weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

S-Evans Biosciences Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlie Xiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Charle Xiang, Doctor

Role: CONTACT

86-571-87236426

Facility Contacts

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Charlie Xiang, Doctor

Role: primary

86-571-87236426

Other Identifiers

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SEB-2014-2-20

Identifier Type: -

Identifier Source: org_study_id

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