Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research

Acute Lung Injury Clinical Trial

Official title:

Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951882
• Other study ID #: 2020-592
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 9, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patients suffered from acute lung ininjury (200<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1.= 3 days (72h)

• 2.Age =18 years, =65 years

• 3.200<PaO2/FiO2 = 300

• 4.Chest X-ray/chest CT : infiltrates of both lungs

• 5.Need assisted ventilation (ventilation or high flow oxygen therapy)

• 6.No left heart failure, pulmonary edema

• 7.Agree to participate and signe an informed consent

Exclusion Criteria:

• 1.Life expectancy <3 months due to non-respiratory failure

• 2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation

• 3.History of HIV, malignant tumors, or impaired immune function

• 4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.)

• 5.Pregnancy

• 6.Have a serious concomitant disease

• 7.Unable to follow-up

• 8.History of severe allergic reactions or allergy to saline and serum

• 9.Already participated in another clinical study within 12 weeks

• 10.Pulmonary edema caused by other underlying diseases

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Wounds and Injuries

Intervention

Biological:
• human derived umbilical cord derived mesenchymal stem cells
intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells

Locations

Country	Name	City	State
China	SAHZU	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IL-6	inflammatory factors	Day 1
Other	IL-6	inflammatory factors	Day 7
Other	IL-6	inflammatory factors	Day 14
Other	IL-6	inflammatory factors	Day 28
Other	IL-8	inflammatory factors	Day 1
Other	IL-8	inflammatory factors	Day 7
Other	IL-8	inflammatory factors	Day 14
Other	IL-8	inflammatory factors	Day 28
Other	TNF-a	inflammatory factors	Day 3
Other	TNF-a	inflammatory factors	Day 7
Other	TNF-a	inflammatory factors	Day 14
Other	TNF-a	inflammatory factors	Day 28
Primary	PaO2/FiO2	Oxygenation index	Day 3
Primary	PaO2/FiO2	Oxygenation index	Day 7
Primary	PaO2/FiO2	Oxygenation index	Day 14
Primary	PaO2/FiO2	Oxygenation index	Day 28
Secondary	the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 3
Secondary	the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 7
Secondary	the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 14
Secondary	the days of ventialtion and hospital stay	the length of ventilation and hospital stay	Day 28