Acute Myocardial InfarctionPhase 1/2NCT02666391
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Acute Myocardial Infarction and Myocardial Infarction, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy
- What is being tested?
- umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
- LVEF (left ventricular ejection fraction): 25-45%;
- Age between 18 and 70, borh gender;
- Women of childbearing age agreed to take contraceptive measures during the whole study period;
- No psychiatric illnesses and speaking dysfunction;
- Informed consent.
Who cannot join
- Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
- Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
- Patients suffered from severe arrhythmia;
- Patients suffered from stent thrombosis;
- Patients receiving immunosuppressive therapy;
- Patients have tumor or other lethal diseases (expectation of life<6 months);
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- Women who plan to be pregnant or are pregnant or nursing;
- Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
- Other clinical trial participants within 3 months;
- Investigators judge other conditions not suitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.
- Being tested
- umbilical cord mesenchymal stem cells
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs | Experimental | Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs) Receives: Biological: umbilical cord mesenchymal stem cells |
| controls | No intervention | Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
Measured: 1 week, 6 month, 12 month,18 month
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
Measured: 1 week, 18 month
Secondary outcomes (3)
Pump failure Killip classification
Measured: baseline, 1 week, 1 month, 6 month, 12 month,18 month
New York Heart Association(NYHA) classification
Measured: 1 week, 1 month, 6 month, 12 month,18 month
Occurrence of major adverse event
Measured: 3 day, 1 week, 1 month, 6 month, 12 month,18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666391
- Sponsor's protocol ID
- UCMSC-2
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.
PubMed 23651816
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)
- ClinicalTrials.gov ID
- NCT02666391
- Acronym / sponsor ID
- UCMSC-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- 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.
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSCs | Experimental | Biological: umbilical cord mesenchymal stem cellsIntracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs) |
| controls | No intervention | –Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
- LVEF (left ventricular ejection fraction): 25-45%;
- Age between 18 and 70, borh gender;
- Women of childbearing age agreed to take contraceptive measures during the whole study period;
- No psychiatric illnesses and speaking dysfunction;
Key exclusion criteria (10 listed)
- Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
- Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
- Patients suffered from severe arrhythmia;
- Patients suffered from stent thrombosis;
- Patients receiving immunosuppressive therapy;
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 |
|---|---|---|
| umbilical cord mesenchymal stem cells | Biological | UCMSCs |
Primary outcome
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography.
Time frame: 1 week, 6 month, 12 month,18 month
Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT).
Time frame: 1 week, 18 month
3 secondary outcomes
Pump failure Killip classification
Time frame: baseline, 1 week, 1 month, 6 month, 12 month,18 month
New York Heart Association(NYHA) classification
Time frame: 1 week, 1 month, 6 month, 12 month,18 month
Occurrence of major adverse event
Time frame: 3 day, 1 week, 1 month, 6 month, 12 month,18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 23651816Gao LR, Pei XT, Ding QA, Chen Y, Zhang NK, Chen HY, Wang ZG, Wang YF, Zhu ZM, Li TC, Liu HL, Tong ZC, Yang Y, Nan X, Guo F, Shen JL, Shen YH, Zhang JJ, Fei YX, Xu HT, Wang LH, Tian HT, Liu DQ, Yang Y. A critical challenge: dosage-related efficacy and acute complication intracoronary injection of autologous bone marrow mesenchymal stem cells in acute myocardial infarction. Int J Cardiol. 2013 Oct 9;168(4):3191-9. doi: 10.1016/j.ijcard.2013.04.112. Epub 2013 May 4.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cells in people with Acute Myocardial Infarction and Myocardial Infarction, run by South China Research Center for Stem Cell and Regenerative Medicine.
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 6 inclusion and 10 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Xuetao Pei, M.D., Ph.D (8610-68164807, AMMS0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global left ventricular ejection fraction (LVEF)measured by echocardiography. (time frame: 1 week, 6 month, 12 month,18 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666391, which also lists 1 linked publication.
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 28 Jan 2016.