Chronic Ischemic Heart DiseasePhase 1/2UCMSC-HeartNCT02439541
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy
A Phase 1/2 study testing UCMSC group in people with Chronic Ischemic Heart Disease and Heart Failure, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Ischemic Heart Disease, Heart Failure, Angina
- What is being tested?
- UCMSC group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 y
- No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
- Maximal tolerable angina and heart failure medication
- NYHA functional classification (I-III)
- Signed informed consent
Who cannot join
- Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
- Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
- History with malignant disease within 5 y of inclusion or suspected malignity
- Severe heart failure (NYHA functional classification IV)
- Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
- Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
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- Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
- Patients with reduced immune response or treated with immunosuppressive medication
- Combined with severe infectious diseases
- Pregnant or fertile women
- Socially and mentally disabilities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071
Xiaozhong Zhang, M.D, +86-010-66947136, zxz947136@126.com
About this study
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.
Read the detailed description
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.
Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.
Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
- Conditions
- Chronic Ischemic Heart Disease, Heart Failure, Angina
- Being tested
- UCMSC group
- Keywords
- cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation
- Medical subject headings
- Heart Failure, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSC groupBiological
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)
| Study group | Role | What they receive |
|---|---|---|
| UCMSC group | Experimental | Patients in this arm received umbilical cord MSCs by intracoronary injection Receives: Biological: UCMSC group |
| Control group | No intervention | Patients in this arm did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and nature of adverse events
Evidence for new clinical/biological abnormalities.
Measured: Within the first year after intracoronary infusion
Incidence of major adverse coronary events (MACE)
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
Measured: Within the first year after intracoronary infusion
Secondary outcomes (4)
Exercise Time and Level
Exercise time and level as assessed via six minute walk test.
Measured: Post cell transplantation: 1, 3, 6, 12 months
Quantify myocardium perfusion measured by SPECT
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
Measured: Post cell transplantation: 6, 12 months
Assessment of heart function by left ventricular ejection fraction
Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
Measured: Post cell transplantation: 1, 3, 6，12 months
Clinical Improvement in NYHA Classification
The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Bing Liu, M.D, Study chair, 307-IVY Translational Medicine CenterXiaozhong Zhang, M.D, Principal investigator, Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439541
- Sponsor's protocol ID
- 307-IVY-SC-001
- Acronym
- UCMSC-Heart
- Status last verified
- Mar 2016
- First submitted
- 5 May 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02439541
- Acronym / sponsor ID
- UCMSC-Heart / 307-IVY-SC-001
- Conditions
- Chronic Ischemic Heart Disease, Heart Failure, Angina
- Keywords
- cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 May 2015 (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.
Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.
Detailed description
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.
Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.
Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSC group | Experimental | Biological: UCMSC groupPatients in this arm received umbilical cord MSCs by intracoronary injection |
| Control group | No intervention | –Patients in this arm did not receive any intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 y
- No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
- Maximal tolerable angina and heart failure medication
- NYHA functional classification (I-III)
- Signed informed consent
Key exclusion criteria (11 listed)
- Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
- Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
- History with malignant disease within 5 y of inclusion or suspected malignity
- Severe heart failure (NYHA functional classification IV)
- Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
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 |
|---|---|---|
| UCMSC groupHuman umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7) | Biological | UCMSC group |
Primary outcome
Number and nature of adverse events
Time frame: Within the first year after intracoronary infusion
Evidence for new clinical/biological abnormalities.
Incidence of major adverse coronary events (MACE)
Time frame: Within the first year after intracoronary infusion
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
4 secondary outcomes
Exercise Time and Level
Time frame: Post cell transplantation: 1, 3, 6, 12 months
Quantify myocardium perfusion measured by SPECT
Time frame: Post cell transplantation: 6, 12 months
Assessment of heart function by left ventricular ejection fraction
Time frame: Post cell transplantation: 1, 3, 6，12 months
Clinical Improvement in NYHA Classification
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Bing Liu, M.D study chair
307-IVY Translational Medicine Center
Xiaozhong Zhang, M.D principal investigator
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
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 UCMSC group in people with Chronic Ischemic Heart Disease and Heart Failure, run by Affiliated Hospital to Academy of Military Medical Sciences 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 16 Mar 2016. 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 Xiaozhong Zhang, M.D (+86-010-66947136, zxz947136@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and nature of adverse events (time frame: Within the first year after intracoronary infusion). 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?
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 16 Mar 2016.