NCT02095444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

March 16, 2014

Last Update Submit

March 20, 2014

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • The degree of lung injury

    14 days

Study Arms (1)

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

Menstrual blood stem cellsDRUG

10\*7 cells/kg, intravenous injection for 4 times during two weeks

Menstrual blood stem cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of H7N9 infection
  • must be critical injured for lung tissues

You may not qualify if:

  • cancer diseases
  • pregnancy
  • mental disorder
  • allergic constitution
  • severe inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeMultiple Organ Failure

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charlie Xiang, Doctor

    State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charle Xiang, Doctor

CONTACT

86-571-87236426cxiang@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2014

First Posted

March 24, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

CN(1)