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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

About this trial

This is an interventional treatment trial for Acute Lung Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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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