Trial | NCT02444455  Report issue

Title

Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
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.
Study Started
May 31
2015
Primary Completion
Mar 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
May 14
2015
Estimate

Biological UCMSC group

Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.

UCMSC group Experimental

Human umbilical cord MSCs are administrated to patients by intravenous infusion

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
No Results Posted