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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02095444
Recruitment Status : Unknown
Verified March 2014 by S-Evans Biosciences Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 24, 2014
Last Update Posted : March 24, 2014
First Affiliated Hospital of Zhejiang University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Acute Respiratory Distress Syndrome (ARDS) Multiple Organ Failure Drug: Menstrual blood stem cells Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase1 Study of Recombinant Stem Cells That Repair Lung Injury in H7N9 Infected Patients
Study Start Date : March 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

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

Primary Outcome Measures :
  1. The degree of lung injury [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02095444

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Contact: Charle Xiang, Doctor 86-571-87236426

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China, Zhejiang
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Charlie Xiang, Doctor    86-571-87236426   
Sponsors and Collaborators
S-Evans Biosciences Co., Ltd.
First Affiliated Hospital of Zhejiang University
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Principal Investigator: Charlie Xiang, Doctor State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: S-Evans Biosciences Co., Ltd. Identifier: NCT02095444    
Other Study ID Numbers: SEB-2014-2-20
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Multiple Organ Failure
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Pathologic Processes