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Trial record 61 of 500 for:    stem cell pulmonary disease

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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02095444


Contacts
Contact: Charle Xiang, Doctor 86-571-87236426 cxiang@zju.edu.cn

Locations
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    cxiang@zju.edu.cn   
Sponsors and Collaborators
S-Evans Biosciences Co.,Ltd.
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

Responsible Party: S-Evans Biosciences Co.,Ltd.
ClinicalTrials.gov Identifier: NCT02095444     History of Changes
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:
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes
Wounds and Injuries
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Multiple Organ Failure
Thoracic Injuries
Shock