Ischemic CardiomyopathyPhase 1NCT01946048
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy
A Phase 1 study testing mesenchymal stem cells in people with Ischemic Cardiomyopathy, run by Hebei Medical University at 1 site in China.
Trial summary
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy . Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 30 to 80 years
- ischemic cardiomyopathy
- Left ventricular infarction area seriously low movement to no movement
- The low whole left ventricular systolic function (LVEF 45% or less)
- Have line or quasi coronary interventional treatment
- Willing to accept patients with follow-up evaluation
- Have signed informed consent form approved by the ethics committee
Who cannot join
- Non elevation between S-wave and T-wave in patients with acute myocardial infarction
- No function damage in patients with acute myocardial infarction
- Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
- Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
- Acute infectious diseases
- Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
Show all 18Show fewer
- Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L
- Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal
- Unstable cerebral lesions
- malignant tumor
- Cognitive dysfunction and dementia patients, patients with severe mental illness
- Patients with severe physical disabilities can't regular follow-up
- Other serious uncontrolled system disease
- To prepare or have the pregnancy women patients
- Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
- Cannot use the test dose atorvastatin
- Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
- Patients unable or unwilling to sign a consent form
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Read the detailed description
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
Procedure: Selected patients were randomly divided into a cell therapy group and a control group.
Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells. Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The examination of heart function
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
Measured: Post cell transplantation: 1, 3, 6 months
Secondary outcomes (3)
all-cause mortality
Measured: Post cell transplantation: one year
all-cause morbidity
Measured: Post cell transplantation: one year
major adverse cardiac and cerebrovascular events
Measured: Post cell transplantation: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanhai Li, Hebei Medical University
- Investigators
- Baoyong Yan, Doctor, Study chair, The First Hospital of Hebei Medical UniversityGang Liu, Doctor, Study director, The First Hospital of Hebei Medical UniversityGuoping Ma, Master, Principal investigator, The First Hospital of Hebei Medical UniversityJun Zhang, Master, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946048
- Sponsor's protocol ID
- 12276102D-Cardiac Disease
- Status last verified
- Oct 2013
- First submitted
- 12 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01946048
- Acronym / sponsor ID
- 12276102D-Cardiac Disease
- Conditions
- Ischemic Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Sep 2013 (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 aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Detailed description
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cellsStem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 30 to 80 years
- ischemic cardiomyopathy
- Left ventricular infarction area seriously low movement to no movement
- The low whole left ventricular systolic function (LVEF 45% or less)
- Have line or quasi coronary interventional treatment
Key exclusion criteria (18 listed)
- Non elevation between S-wave and T-wave in patients with acute myocardial infarction
- No function damage in patients with acute myocardial infarction
- Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
- Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
- Acute infectious diseases
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 |
|---|---|---|
| mesenchymal stem cellsProcedure: Selected patients were randomly divided into a cell therapy group and a control group. Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million. | Biological | mesenchymal stem cells |
Primary outcome
The examination of heart function
Time frame: Post cell transplantation: 1, 3, 6 months
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
3 secondary outcomes
all-cause mortality
Time frame: Post cell transplantation: one year
all-cause morbidity
Time frame: Post cell transplantation: one year
major adverse cardiac and cerebrovascular events
Time frame: Post cell transplantation: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Baoyong Yan, Doctor study chair
The First Hospital of Hebei Medical University
Gang Liu, Doctor study director
The First Hospital of Hebei Medical University
Guoping Ma, Master principal investigator
The First Hospital of Hebei Medical 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 study testing mesenchymal stem cells in people with Ischemic Cardiomyopathy, run by Hebei Medical University 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 7 inclusion and 18 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 8 Oct 2013. 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 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?
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?
The examination of heart function (time frame: Post cell transplantation: 1, 3, 6 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 8 Oct 2013.