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

March 20, 2014 updated by: S-Evans Biosciences Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Menstrual blood stem cells
1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.
Drug: Menstrual blood stem cells
10*7 cells/kg, intravenous injection for 4 times during two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of lung injury
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S-Evans Biosciences Co., Ltd.

Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Charlie Xiang, Doctor, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 16, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-2014-2-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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