Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

— UCMSC-ALI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444455
• Other study ID #: 307-IVY-SC-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 8, 2015
• Last updated: May 11, 2015
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Changqing Bai, M.D.
• Phone: +86-010-66947356
• Email: baicq307[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
China	Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	Ivy Institute of Stem Cells Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be determined by the assessment of major adverse events	Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.	From day 0 at the start of treatment to day 14.	Yes
Secondary	Quantify pulmonary respiratory function measured by chest computerized tomography		Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.	No
Secondary	The efficacy of UC-MSC treatment was measured by arterial blood gas analysis		Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.	No
Secondary	The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation,IL-6		6 hours post-infusion, and days 1, 2, and 3	No
Secondary	The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation,IL-8		6 hours post-infusion, and days 1, 2, and 3	No