Ischemic Heart DiseasePhase 1NCT04996966
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
A Phase 1 study testing human umbilical cord-derived mesenchymal stem cells and saline in people with Ischemic Heart Disease and Lung Injury, run by Shanghai East Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Lung Injury, Non-cardiac Surgery
- What is being tested?
- human umbilical cord-derived mesenchymal stem cells and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Lijun Liao contact
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital, Shanghai Tongji University
Shanghai, 200120
Zhongmin Liu, +86-021-38804518, liu.zhongmin@tongji.edu.cn
About this study
Official title: Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease
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.
Read the detailed description
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. The research process is as follows: 1. Sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or hUC-MSCs treatment group (n=8); 2. Knee replacement was performed under general anesthesia in both groups. In the cell therapy 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. Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection, all 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
- Being tested
- human umbilical cord-derived mesenchymal stem cells, saline
- Keywords
- human umbilical cord-derived mesenchymal stem cells, lung injury
- Medical subject headings
- Myocardial Ischemia, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord-derived mesenchymal stem cellsBiological
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.
salineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: human umbilical cord-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index
The change in oxygenation index after the operation
Measured: Before the operation, 6 hours, 3days, and 7days after the MSCs injection
Secondary outcomes (20)
The value of arterial blood cLAC
The change in arterial blood cLAC after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of IL-1β
The change in venous blood IL-1β after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of IL-6
The change in venous blood IL-6 after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of TGF-α
The change in venous blood TGF-α after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of HMGB1
The change in venous blood HMGB1 after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of IL-10
The change in venous blood IL-10 after the operation
Measured: Before the operation and 7days after the MSCs injection
The content of B-type natriuretic peptide (BNP)
The change in venous blood B-type natriuretic peptide after the operation
Measured: Before the operation and 7days after the MSCs injection
electrocardiogram
The change in electrocardiogram after the operation
Measured: Before the operation, 7days, and 28 days after the MSCs injection
The average length of stay in hospital
The change in the length of stay in hospital between the two groups
Measured: The average length of stay in hospital
The visual analog scale（VAS）score
The change in VAS score after the operation，the minimum value is 0 and the maximum value is 10, the higher scores mean a worse outcome.
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The hospital for special surgery (HSS) Knee Score
The change in HSS Knee Score after the operation, the minimum value is 0 and the maximum value is 100, the higher scores mean a better outcome.
Measured: Before the operation, 7days, and 28 days after the MSCs injection
The New York Heart Association (NYHA) Functional Classification
The change in NYHA Functional Classification after the operation, the lowest level is Class I and the highest level is Class IV, the higher level mean a worse outcome.
Measured: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
The 36-Item Short Form Survey (SF-36)
The change in SF-36 after the operation, the minimum value is 40 and the maximum value is 850, the higher scores mean a better outcome.
Measured: Before the operation and 28 days after the MSCs injection
The Hamilton Anxiety Scale
The change in degree of anxiety after the operation, the minimum value is 0 and the maximum value is 56, the higher scores mean a worse outcome.
Measured: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
The incidence of allergic reaction
The allergic reaction after the MSCs injection
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The body temperature
The body temperature before and after the operation
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The pulse rate
The pulse rate before and after the operation
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The respiration rate
The respiration rate before and after the operation
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The blood pressure
The blood pressure before and after the operation
Measured: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The content of C-reactive protein (CRP)
The change in venous blood CRP after the operation
Measured: Before the operation and 7 days after the MSCs injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Aug 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangrui Wang, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996966
- Sponsor's protocol ID
- DFDA-001
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT04996966
- Acronym / sponsor ID
- DFDA-001
- Conditions
- Ischemic Heart Disease, Lung Injury, Non-cardiac Surgery
- Keywords
- human umbilical cord-derived mesenchymal stem cells, lung injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The research process is as follows: 1. Sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or hUC-MSCs treatment group (n=8); 2. Knee replacement was performed under general anesthesia in both groups. In the cell therapy 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. Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection, all patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: salineIn 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. |
| MSCs injection | Experimental | Biological: human umbilical cord-derived mesenchymal stem cellsIn 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human umbilical cord-derived mesenchymal stem cellsIn 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 | MSCs injection |
| salineIn 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 | control |
Primary outcome
oxygenation index
Time frame: Before the operation, 6 hours, 3days, and 7days after the MSCs injection
The change in oxygenation index after the operation
20 secondary outcomes
The value of arterial blood cLAC
Time frame: Before the operation and 7days after the MSCs injection
The content of IL-1β
Time frame: Before the operation and 7days after the MSCs injection
The content of IL-6
Time frame: Before the operation and 7days after the MSCs injection
The content of TGF-α
Time frame: Before the operation and 7days after the MSCs injection
The content of HMGB1
Time frame: Before the operation and 7days after the MSCs injection
The content of IL-10
Time frame: Before the operation and 7days after the MSCs injection
The content of B-type natriuretic peptide (BNP)
Time frame: Before the operation and 7days after the MSCs injection
electrocardiogram
Time frame: Before the operation, 7days, and 28 days after the MSCs injection
The average length of stay in hospital
Time frame: The average length of stay in hospital
The visual analog scale（VAS）score
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The hospital for special surgery (HSS) Knee Score
Time frame: Before the operation, 7days, and 28 days after the MSCs injection
The New York Heart Association (NYHA) Functional Classification
Time frame: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
The 36-Item Short Form Survey (SF-36)
Time frame: Before the operation and 28 days after the MSCs injection
The Hamilton Anxiety Scale
Time frame: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
The incidence of allergic reaction
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The body temperature
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The pulse rate
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The respiration rate
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The blood pressure
Time frame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
The content of C-reactive protein (CRP)
Time frame: Before the operation and 7 days after the MSCs injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun Liao contact
Xiangrui Wang principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human umbilical cord-derived mesenchymal stem cells and saline in people with Ischemic Heart Disease and Lung Injury, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangrui Wang (+86-021-38804518-22198, xiangruiwang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index (time frame: Before the operation, 6 hours, 3days, and 7days after the MSCs injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.