Left Ventricular DysfunctionPhase 1NCT03902067
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
A Phase 1 study testing UC-MSC in people with Left Ventricular Dysfunction and Acute Myocardial Infarction, run by Shanghai Life Science & Technology at 1 site in China.
Trial summary
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Left Ventricular Dysfunction, Acute Myocardial Infarction
- What is being tested?
- UC-MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
- Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
- Good compliance, willing to take drugs and follow up according to the requirements of the plan;
- Life expectancy exceeds one year.
Who cannot join
- Those who cannot tolerate cell therapy;
- Patients with severe hepatic and renal insufficiency (ALT>1.5 times the upper limit of normal value, Cr >1.5 times the upper limit of normal value);
- Patients with malignant tumors or extremely weak patients;
- Patients with severe infection;
- Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
- Patients with other serious systemic diseases and organ dysfunction;
Show all 9Show fewer
- Patients with cardiogenic shock;
- Patients with hemorrhagic diseases;
- Researchers believe that anyone who is not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
Read the detailed description
In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.
- Being tested
- UC-MSC, Control Group
- Keywords
- AMI
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCBiological
Also called Transplantation Group
0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability>80%, and endotoxin<0.1 EU， at the concentration of 2x10(7) cells/ml.
Control GroupBiological
Routine treatment without catheter infusion
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC | Experimental | UC-MSC transplantation Receives: Biological: UC-MSC |
| Control Group | Placebo comparator | Routine treatment Receives: Biological: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured as the number of Major Adverse Cardiac Events (MACE)
Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc.
Measured: 12 months
Secondary outcomes (1)
Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up
left ventricular ejection fraction measured by magnetic resonance imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: budget control
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Life Science & Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Sponsor
- Investigators
- Chengxing Shen, Dr., Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902067
- Sponsor's protocol ID
- ShanghaiLST-ucmsc-ami01
- Status last verified
- May 2026
- First submitted
- 28 Mar 2019
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03902067
- Acronym / sponsor ID
- ShanghaiLST-ucmsc-ami01
- Keywords
- AMI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: budget control
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Life Science & TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Apr 2019 (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.
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
Detailed description
In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSC | Experimental | Biological: UC-MSCUC-MSC transplantation |
| Control Group | Placebo comparator | Biological: Control GroupRoutine treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
- Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
- Good compliance, willing to take drugs and follow up according to the requirements of the plan;
- Life expectancy exceeds one year.
Key exclusion criteria (9 listed)
- Those who cannot tolerate cell therapy;
- Patients with severe hepatic and renal insufficiency (ALT>1.5 times the upper limit of normal value, Cr >1.5 times the upper limit of normal value);
- Patients with malignant tumors or extremely weak patients;
- Patients with severe infection;
- Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
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 |
|---|---|---|
| UC-MSCAlso: Transplantation Group0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability>80%, and endotoxin<0.1 EU， at the concentration of 2x10(7) cells/ml. | Biological | UC-MSC |
| Control GroupRoutine treatment without catheter infusion | Biological | Control Group |
Primary outcome
Safety measured as the number of Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc.
1 secondary outcome
Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Chengxing Shen, Dr. principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's 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 UC-MSC in people with Left Ventricular Dysfunction and Acute Myocardial Infarction, run by Shanghai Life Science & Technology 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 9 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: withdrawn, as of the sponsor's last update on 11 May 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured as the number of Major Adverse Cardiac Events (MACE) (time frame: 12 months). 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 11 May 2026.