Clinical trial NCT02444455: Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
Official title: Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: cellular therapy
acute lung injury
acute respiratory distress snydrome
human umbilical cord mesenchymal stem cell
phase 1/2 clinical study
allogeneic stem cell transplantation
ALI
ARDS
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ivy Institute of Stem Cells Co. Ltd
First posted: 2015-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.

Detailed description: Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.

Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.

Clinical results will be analyzed after completion of 14 days of followup.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age between 35 and 70 y
* Acute onset within 7 days.
* Oxygenation index:200\<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2\>35mmHg
* Bilateral infiltrates on chest radiography
* No cardiac failure

Exclusion Criteria:

* Declined to sign informed consent
* Socially and mentally disabilities
* Malignant diseases
* Combined with severe infectious diseases
* Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
* Pregnant or perinatal women
* Severe diseases of any major organs

Primary outcomes:
measure: Safety will be determined by the assessment of major adverse events
timeFrame: From day 0 at the start of treatment to day 14.
Secondary outcomes:
measure: Quantify pulmonary respiratory function measured by chest computerized tomography
timeFrame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
measure: The efficacy of UC-MSC treatment was measured by arterial blood gas analysis
timeFrame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
measure: The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6
timeFrame: 6 hours post-infusion, and days 1, 2, and 3
measure: The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8
timeFrame: 6 hours post-infusion, and days 1, 2, and 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: 307-IVY Translational Medicine Center
name: Bing Liu, M.D.
role: STUDY_CHAIR
affiliation: Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
name: Changqing Bai, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
name: Huiying Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: