Using Human Menstrual Blood Cells to Treat Acute Lung Inj... | NCT02095444

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

NCT02095444

Sponsor

S-Evans Biosciences Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 24, 2014Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Acute Lung Injury
Acute Respiratory Distress Syndrome (ARDS)
Multiple Organ Failure

Interventions

Menstrual blood stem cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 16, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2014

Last Update Posted Date

Mar 24, 2014Estimated

Name	Class
First Affiliated Hospital of Zhejiang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Menstrual blood stem cells	Experimental	1x10*7 cells/kg, IV(in the vein) twice a week. Number of course for two weeks.	Drug: Menstrual blood stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Menstrual blood stem cells	Drug	10*7 cells/kg, intravenous injection for 4 times during two weeks	Menstrual blood stem cells

Measure	Description	Time Frame
The degree of lung injury		14 days

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charle Xiang, Doctor	Contact	86-571-87236426		cxiang@zju.edu.cn

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital	Recruiting	Hangzhou	Zhejiang	310003	China

Condition Browse Module

MeSH Terms

ID	Term
D055371	Acute Lung Injury
D012128	Respiratory Distress Syndrome
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided