Ischaemic Heart Disease

Stem cells from bone marrow, fat and heart tissue are being investigated as possible treatments for heart disease. Click on the link provided to find out more about each trial. It remains too early to know which approach will be most suitable. We need evidence collected in clinical trials to determine if a proposed stem cell treatment is both safe and effective.

tagged as Ischaemic Heart Disease

  • Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina Location: Canada
    Overview: This study seeks to compare heart function in two groups of 220 patients with Chronic Myocardial Ischaemic disease and refractory angina. The study is being conducted by Baxter Healthcare in Canada. One group of patients will be administered an injection of their own blood stem cells as well as conventional therapy (interventional group). The second group will only receive conventional therapy (control group). Participants will be given a drug (G-CSF) which releases blood stem cells (Haematopoietic CD 34+ stem cells) from the bone marrow into their circulation. Stem cells will be collected in a process called plasmapheresis. The control group will receive placebo injections. Changes in Cardiac Exercise Tolerance and angina will be measured in both the groups for a period of 12 months after the injections. The study commenced in April 2012 and is expected to be completed by June 2016.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia Location: US
    Overview: This trial is seeking to assess the role of ‘regenerative cells’ isolated from fat in patients with chronic myocardial ischaemia. Cells will be collected from the participants using liposuction. The trial will be conducted at five centres in the US by Cyton Therapeutics and hopes to enrol 45 patients with chronic myocardial ischaemia that has not responded to standard treatments. Participants will be randomly allocated to a treatment group which will receive injections of ‘regenerative cells’ directly into the heart, or into a control group which will receive a placebo injection into the heart. Participants will be assessed for complications and changes in cardiac function and cardiac ischaemia six months after receiving the treatment.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Stem Cell Injection to Treat Heart Damage During Open Heart Surgery Location: US
    Overview: The trial is being conducted by the National Institute of Health Clinical Centre in Bethesda, Maryland and seeks to investigate the role of the patient’s own stem cells to repair heart damage. Participants will be have their own bone marrow stem cell cells collected about 3 weeks before surgery and then have the cells injected directly into damaged areas of the heart during open-heart surgery.  Participants will be assessed for safety and feasibility of such an injection as well as changes in heart function. The trial expects to recruit 24 subjects between February 2012 and September 2013.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery (COAT) Location: India
    Overview: This trial aims to investigate if the patient’s own bone marrow stem cells can assist following recent myocardial infarct. The trial is being conducted at the All India Institute of Medical Sciences in New Delhi and seeks to recruit 40 patients that have had a myocardial infarction in the last six months and have persistent coronary artery occlusion. The patients will be randomised to either the control group that will receive only coronary artery dilation and stenting, or the experimental group that will receive an infusion of their own bone marrow cells directly into the heart muscle in addition to coronary artery dietician and stenting. Participants will be monitored for complications and for changes in cardiac function and functional capacity. The trial is expected to complete in September 2014.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy Location: Ukraine
    Overview: This trial is designed to investigate the effects of the patient's own stem cells in myocardial ischemia. The trial is being conducted by the Odessa National Medical University and seeks to enrol 50 patients with ischaemic heart disease. The trial aims to investigate whether the patient's own blood stem cells (CD34+ stem cells) improves outcomes. Participants will receive either conventional therapy (control group) or conventional therapy and stem cells (experimental group). In the experimental group, the stem cells will be injected into the heart muscle. Participants will be monitored for any complications and any changes in heart function (specifically global left ventricular ejection fraction and regional wall motion score index) three and six months after treatment. The study commenced in 2012 and is expected to run until January 2015.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • A Clinical Trial of Allogeneic Mesenchymal Precursor Cells in the Treatment of Heart Attacks Location: Netherlands
    Overview: This trial aims to determine the safety and effectiveness of using donated mesenchymal precursor cells following a heart attack. The trial is being conducted in 11 countries and is sponsored by Mesoblast Inc. To be included in the trial the damage to the heart (the infarct) must involve either some or complete blockage of the left coronary artery (referred to as ST-elevation myocardial infarction) and require treatment. Participants will be randomly divided into three groups. The first group will receive standard treatment (control group). The other two groups will receive different doses of mesenchymal precursor cell obtained from donated bone marrow. Participants will be monitored for complications and assessed in heart function. The trial expects to enrol 225 participants by March 2015.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. Location: Poland
    Overview: This trial aims to evaluate the effectiveness of treating patients with heart disease using bone marrow stem cells administered directly into the muscle of left ventricle. The trial is being conducted at the Silesian Medical University in Katowice. To be part of the study, participants will have angina which does not respond to standard drug treatment and myocardial ischemia without possibility of effective revascularization. Participants will be randomly divided into two groups. One group will receive their own bone marrow stem cells (CD133+) directly into the heart muscle (experimental group). The other group will receive only a placebo injection (control group). Participants will be monitored for complications and changes in their clinical condition. The trial commenced in June 2012 and expects to enrol 60 patients.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Randomized,Open Labled, Multicenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells Acute Myocardial Infarction Location: South Korea
    Overview: This trial aims to investigate the effects of the patient's own mesenchymal stem cells in the treatment of acute myocardial infarction. The trial is being conducted at the Severance Hospital, Yonsei University College of Medicine and several other centres in Korea in conjunction with Pharmicell Co Ltd. The trial proposes to enrol 135 participants with an acute myocardial infarction between December 2012 and January 2014. Participants will be randomly divided into three groups. A control group will receive conventional treatment only. One experimental group will receive a single injection of their own expanded bone marrow derived mesenchymal stem cells. While a second experimental group will receive two injections of their stem cells one month apart. Participants will be monitored for complications and changes in their clinical condition including changes in left ventricular ejection fraction (LVEF) as measured by MRI.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Autologous Human Cardiac-derived Stem Cell to Treat Ischemic Cardiomyopathy Location: Japan
    Overview: The aim of this trial is to evaluate the safety and effectiveness of transplanting stem cells in patients with severe heart failure due to chronic ischemic cardiomyopathy. The trial is being conducted by the Kyoto Prefecture University of Medicine, the Asahikawa Medical College and the National Cerebral and Cardiovascular Centre Translation Research Informatics Centre in Kobe. The cells used in the trial have been obtained from donated bone marrow mesenchymal stem cells and have been able to grow into heart stem cells in the laboratory (also referred to as Cardiac Stem Cell progenitor cells). Participants in this study will receive an infusion of the hCSC stem cells into a major heart artery, as well as a growth factor directly into the heart muscle around known infarcted areas. Participants will be monitored for complications and changes in their condition. The trial aims to recruit six patients by end 2013.
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure Location: Japan
    Overview: This trial aims to evaluate the use of the patient's own stem cells for heart failure. The trial is being conducted at the Kanazawa University Hospital in Ishikawa and proposes to recruit six patients with ischaemic heart failure (Left Ventricular Ejection Fraction less than 40 %) between August 2012 and September 2014. All participants will have stem cells harvested from their own fat and injected directly into the coronary arteries via cardiac catheterisation. Participants will be monitored for complications and changes in clinical condition
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Not yet started
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients with Ischemic Dilated Cardiomyopathy Location: Malaysia
    Overview: This trial aims to investigate the role of the patient's own stem cells in cardiomyopathy. The trial is being conducted by the National University of Malaysia in conjunction with Cytopeutics Pte Ltd and proposes to recruit 80 patients with end stage cardiomyopathy that has not responded to conventional therapy. Participants will be randomly divided between two groups. A control group will receive only conventional therapy, while an experimental group will receive mesenchymal stem cells obtained from their own bone marrow directly into their heart. Participants will be monitored for complications and changes in clinical condition. This Phase II study follows on from a Phase I study by the same investigators.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Cell Therapy in Severe Chronic Ischemic Heart Disease Location: Brazil
    Overview: This trial aims to investigate of the role of the patient's own bone marrow stem cells in patients with severe, chronic ischaemic heart disease. The trial is being conducted by the Heart Institute São Paulo and the Ministry of Health Brazil at several centres and expects to enrol 200 patients. Participants will be randomly divided into two groups. The experimental group will receive an injection of stem cells from their own bone marrow directly into the heart at the time of the surgery. The control group will receive a placebo injection at the time of the surgery. Participants will be monitored for complications and changes in clinical condition, including left ventricular function and any changes in functional angina. Both the participants and the clinicians will be not be aware of the treatment the patient has received.
    Link to Clinical Registry
    Trial Design: Therapeutic intervention
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells in Patients with ST Segment Elevation Myocardial Infarction Location: Russia
    Overview: This trial aims to investigate the use of stem cells from bone marrow during cardiac stenting for a first time ischaemic myocardial infarction. The trial is being conducted by the Russian Academy of Medical Sciences in Siberia and expects to enrol 85 subjects by September 2014. All participants will need to be diagnosed with a first-time ischaemic cardiac event-ST Elevation Myocardial Infarction (STEMI) and be scheduled for coronary artery stenting. Participants will be randomly divided into three groups. The control group will receive the coronary artery stenting only. The second group will have mesenchymal stem cells from their bone marrow infused at the time of stenting. The third group will have CD 133+ mononuclear cells isolated from their bone marrow infused at the time of stenting. All participants will be monitored for complications following the procedure, and changes in clinical condition including Left Ventricular Ejection Fraction.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Not yet started
    Stem Cell: Adult Bone Marrow Stem Cells
  • Allogeneic Stem Cells Implantation Combined with Coronary Bypass Grafting in Patients with Ischemic Cardiomyopathy Location: Greece
    Overview: This trial aims to investigate the use of donated mesenchymal stem cells injected into the heart at the time of bypass surgery in patients with coronary artery disease and ischaemic cardiomyopathy. The trial is being conducted at the AHEPA University Hospital in Athens and proposes to recruit 30 patients between November 2012 and December 2015. All participants will be monitored for complications following the procedure, and changes in clinical condition, including Left Ventricular Ejection Fraction (LVEF) and myocardial perfusion.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Stem Cells (unspecified)
  • Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure Location: Iran
    Overview: This trial aims to the use of the patient's own heart stem cells in ischemic heart failure. The trial is being conducted at the Royan Institute in Teheran and proposes to recruit 50 patients between December 2012 and December 2015. Participants will be randomly allocated to two groups. The experimental group will receive their own heart stem cells administered via an intracoronary artery (presumably by coronary artery catheterisation). It is unclear from the NIH registry how the cells are harvested and/or expanded in the laboratory. It is also unclear as to how the placebo is delivered in the control group. All participants will be monitored for complications and assessed for changes in their clinical condition including left ventricular ejection fraction.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Stem Cells (unspecified)