Myocardial IschemiaPhase 1/2NCT04939077
Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
A Phase 1/2 study testing Allogeneic Human Umbilical Cord Mesenchymal Stem Cells in people with Myocardial Ischemia and Ventricular Dysfunction, Left, run by Shanghai East Hospital at 1 site in China.
Trial summary
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Myocardial Ischemia, Ventricular Dysfunction, Left
- What is being tested?
- Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2019to 30 Nov 2022
- Phase
- Phase 1/2
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF<40%;
- Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
- After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
- The patient has no mental illness and language dysfunction and can fully understand the treatment method.
Who cannot join
- Does not meet the above selection criteria;
- Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
- There are reasons to suspect that the patient was forced to join the trial;
- Acute left ventricular insufficiency, cardiogenic shock;
- The patient has any infectious diseases (including bacterial and viral infections);
- Others who are clinically considered unsuitable for this treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, 200120
Zhongmin Liu, Doctor, +86-021-38804518, liu.zhongmin@tongji.edu.cn
About this study
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
Read the detailed description
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
- Conditions
- Myocardial Ischemia, Ventricular Dysfunction, Left
- Being tested
- Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
- Medical subject headings
- Myocardial Ischemia, Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Human Umbilical Cord Mesenchymal Stem CellsBiological
In CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG
| Study group | Role | What they receive |
|---|---|---|
| CABG with hUC-MSC treatment group | Experimental | In the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG. Receives: Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells |
| CABG group | No intervention | CABG was performed under general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
The change in Left ventricular ejection fraction (LVEF) % after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end diastolic volume
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end systolic volume
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Stroke volume
The change in Stroke volume (SV) ml after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular apex four-chamber end systolic diameter
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
6 minutes walking distance
The change in 6 minutes walking distance m after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Secondary outcomes (1)
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
Measured: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start27 Nov 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhongmin Liu, Doctor, Principal investigator, Shanghai East Hospital, Shanghai Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939077
- Sponsor's protocol ID
- MR-31-20-000323
- Status last verified
- Jun 2021
- First submitted
- 3 Dec 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
- ClinicalTrials.gov ID
- NCT04939077
- Acronym / sponsor ID
- MR-31-20-000323
- Conditions
- Myocardial Ischemia, Ventricular Dysfunction, Left
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 25 Jun 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 heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
Detailed description
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG with hUC-MSC treatment group | Experimental | Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem CellsIn the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG. |
| CABG group | No intervention | –CABG was performed under general anesthesia. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF<40%;
- Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
- After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
- The patient has no mental illness and language dysfunction and can fully understand the treatment method.
Key exclusion criteria (6 listed)
- Does not meet the above selection criteria;
- Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
- There are reasons to suspect that the patient was forced to join the trial;
- Acute left ventricular insufficiency, cardiogenic shock;
- The patient has any infectious diseases (including bacterial and viral infections);
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 |
|---|---|---|
| Allogeneic Human Umbilical Cord Mesenchymal Stem CellsIn CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG | Biological | CABG with hUC-MSC treatment group |
Primary outcome
Left ventricular ejection fraction
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular ejection fraction (LVEF) % after the operation
Left ventricular end diastolic volume
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Left ventricular end systolic volume
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Stroke volume
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Stroke volume (SV) ml after the operation
Left ventricular apex four-chamber end systolic diameter
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
6 minutes walking distance
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
The change in 6 minutes walking distance m after the operation
1 secondary outcome
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
Time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zhongmin Liu, Doctor principal investigator
Shanghai East Hospital, Shanghai Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Human Umbilical Cord Mesenchymal Stem Cells in people with Myocardial Ischemia and Ventricular Dysfunction, Left, 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 4 inclusion and 6 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 25 Jun 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhongmin Liu, Doctor (+86-021-38804518, liu.zhongmin@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720). The study lists 6 primary outcomes in all. 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 25 Jun 2021.