Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI)

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Acute Respiratory Distress Syndrome

Acute Lung Injury

Treatments

Biological: UCMSC group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02444455

307-IVY-SC-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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