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

• Sponsor: S-Evans Biosciences Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02095444
• Collaborator: First Affiliated Hospital of Zhejiang University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 33.1
• Patients Per Site Per Month: 0.6

Study Details

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.

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The degree of lung injury [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital	Hangzhou	Zhejiang	China	310003

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S-Evans Biosciences Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02095444
• Other Study ID Numbers: SEB-2014-2-20
• First Posted: Mar 24, 2014
• Last Update Posted: Mar 24, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Multiple Organ Failure; Wounds and Injuries

Study Results

No Results Posted as of Mar 24, 2014