Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury

NCT04996966 | Unknown Phase 1

• 1 other identifier: DFDA-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.

Conditions

Ischemic Heart Disease; Lung Injury; Non-cardiac Surgery

Keywords

human umbilical cord-derived mesenchymal stem cells; lung injury

Outcome Measures

Primary Outcomes (1)

• oxygenation index

  The change in oxygenation index after the operation

  Before the operation, 6 hours, 3days, and 7days after the MSCs injection

Secondary Outcomes (20)

• The value of arterial blood cLAC

  Before the operation and 7days after the MSCs injection

• The content of IL-1β

  Before the operation and 7days after the MSCs injection

• The content of IL-6

  Before the operation and 7days after the MSCs injection

• The content of TGF-α

  Before the operation and 7days after the MSCs injection

• The content of HMGB1

  Before the operation and 7days after the MSCs injection

Study Arms (2)

control

PLACEBO COMPARATOR

In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.

Other: saline

MSCs injection

EXPERIMENTAL

In the MSCs injection group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.

Biological: human umbilical cord-derived mesenchymal stem cells

Interventions

human umbilical cord-derived mesenchymal stem cells BIOLOGICAL

In the MSCs injection group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.

MSCs injection

saline OTHER

In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.

control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The electrocardiogram showed T wave change and ST segment depression
• New York Heart Association (NYHA) Classification of cardiac function Ⅰ-Ⅱ level
• The patient who first time to receive knee replacement
• General anesthesia lasted about 2h
• Signed informed consent

You may not qualify if:

• Does not meet the above selection criteria
• Unable to sign the informed consent
• Patients with a malignant tumor, other serious systemic diseases, or psychosis
• Pregnancy, lactation, and those who are not pregnant but do not take effective contraceptives measures
• The patient with a history of an allergic reaction to biological products or drug
• The patient has any infectious diseases (including bacterial and viral infections)
• The patient with cardiac pacemaker implantation within 3 months prior to enrollment
• The patient who had a stroke within 6 months prior to enrollment
• Unable to comply with the agreed timetable of this study
• Patients who are participating in other clinical trials
• Others who are clinically considered unsuitable for this treatment.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Shanghai Tongji University

Shanghai, 200120, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Lung Injury

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xiangrui Wang

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangrui Wang

CONTACT

+86-021-38804518-22198; xiangruiwang@vip.sina.com

Lijun Liao

CONTACT

+86-021-38804518-22198

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 9, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)