Stem Cell Therapy Indications for Cardiovascular Disease in Phase II/III Clinical Trials

By on April 10, 2014
A standard 12-well cell culture dish containing human stem cells placed under an inverted biological microscope for routine inspection.

While there are stem cell therapies in development for several different indications, the number of therapies for cardiovascular disease indications is one of the largest. I have researched stem cell therapies that are in either Phase II or Phase III clinical trials in the United States for cardiovascular disease. For the purposes of this blog, I have only included information about ongoing trials or recently completed trials. I have not included trials that were stopped or were completed previously and have no future trials planned. While I have worked to include all current trials, please let me know if one is missing so that I may add it to the list.

Cardiovascular disease as an indication area includes therapies designated for ischemic heart disease, critical limb ischemia, strokes, myocardial infarction (heart attacks), dilated cardiomyopathy, congestive heart failure and intermittent claudication.

Myocardial Ischemia

Myocardial ischemia, also known as cardiac ischemia or ischemic heart disease happens when blood flow to heart muscle is reduced because of coronary artery blockage, either partial or complete. The blockage reduces the heart’s supply of oxygen and if left untreated can result in myocardial infarction (heart attack).

Clinical Trials for Myocardial Ischemia

Sponsor: Baxter

Phase: Active Phase III clinical trial

Type: Autologous

In this study Baxter is evaluating their product called Renew. Renew is made up of CD34+ stem cells derived from the patient’s bone marrow. Cells are collected and processed then delivered back into the patient through intramycardial injections into targeted areas of the heart. The goal of the current study is to evaluate the Renew’s ability to improve exercise capacity in patients with chronic myocardial ischemia, which will be evaluated at twelve months following treatment. Secondary objectives include a reduction of angina and safety.

Sponsor: Cytori

Phase: Two Phase II clinical trials currently enrolling ATHENA and ATHENA II

Type: Autologous

Cytori’s ATHENA stem cell therapy consists of adipose-derived regenerative cells. The ATHENA trial will look at using Cytori’s stem cell therapy in patients with heart failure due to ischemic heart disease. The ATHENA II trial will look at the use of the Cytori’s cell therapy at a higher cell dose compared to the ATHENA trial.

Myocardial Infarction (Heart Attack)

Myocardial infarction occurs when the heart is denied the necessary supply of oxygen. The heart relies on coronary arteries to deliver oxygenated blood and if one of these arteries becomes blocked it creates cardiac ischemia meaning that the heart is not getting the oxygen it needs. If this persists overtime, the result will be a heart attack where the heart tissue dies. There are approximately 1.5 million heart attacks per year in the United States.

Clinical Trials for Myocardial Infarction

Sponsor: Stemedica

Phase: Recruiting Subjects for a Phase II clinical trial

Type: Allogeneic

Stemedica will be evaluating their product Stemedyne-MSC. Stemedyne-MSC is a human bone derived, ischemia tolerant mesenchymal cell product. During the study, Stemedyne-MSC will be administered intravenously to subjects with ST Segment Elevation Mycardial Infarction.

Sponsor: Neostem

Phase: Active Phase II clinical trial

Type: Autologous

Neostem just completed enrollment for this study in December 2013. The stem cell therapy, AMR-001, is a hematopoietic stem cell product derived from autologous bone marrow. The trial is evaluating the safety and efficacy of infusing AMR-001 into an infarct-related artery for patients who suffer an ST Elevation Myocardial Infarction.

Sponsor: Osiris

Phase: Active Phase II clinical trial

Type: Allogeneic

Osiris’ trial will look at the use of Prochymal to preserve and improve cardiac function after myocardial infarction. Prochymal is an allogenic therapy made up of mesenchymal stem cells derived from donor bone marrow.

Sponsor: Mesoblast
Phase: Recruiting subjects for a Phase II clinical trial

Type: Allogeneic
Mesoblast is evaluating the safety and efficacy of their mesenchymal precursor cell therapy for treatment of myocardial infarction. The stem cell therapy will be infused via intracoronary delivery.

Sponsor: Capricor
Phase: Recruiting subjects for a Phase II clinical trial (ALLSTAR)

Type: Allogeneic
In this study, Capricor will evaluate their ALLSTAR stem cell therapy for myocardial regeneration and reduction in infarct size after myocardial infarction. ALLSTAR is made of heart stem cells.

Congestive Heart Failure

Congestive heart failure occurs when the heart is not pumping efficiently enough to meet oxygen needs of the body. When the body’s oxygen needs aren’t being met, it returns blood to the heart faster than normal and the heart is unable to keep up with the pumping necessary to keep the blood flowing out. Blood then gets congested around the heart.

Clinical Trials for Congestive Heart Failure

Sponsor: Mesoblast
Phase: Cleared by the FDA to begin a Phase III trial

Type: Allogeneic
Mesoblast will begin a Phase III trial of its stem cell therapy comprised of mesenchymal precursor cells. The treatment will consist of a single dose of 150 million allogeneic mesenchymal precursor cells delivered via injection to the left ventricle. “The primary efficacy endpoint of the trial is a time-to-first event analysis of heart failure-related Major Adverse Cardiac Events (HF-MACE), defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events.”

Sponsor: Bioheart
Phase: Active Phase II/III clinical trial

Type: Autologous
In this study, the treatment, Myocell, is injected after heart attack to improve cardiac function. Bioheart uses muscle stem cells (myoblasts). Bioheart manufactures its autologous Myocell by harvesting a small piece of thigh muscle from the patient, then isolating and expanding the myoblasts. The cells are then injected into the patient’s scar tissue in the heart.

Ischemic Stroke

Ischemic strokes happen when there is a blockage in a blood vessel and the blockage prevents or limits blood to the brain. These blockages are caused by fatty deposits along the vessel walls.

Clinical Trials for Ischemic Stroke

Sponsor: Athersys
Phase: Recruiting subjects for a Phase II clinical trial

Type: Allogeneic
The purpose of this study is to evaluate the safety and efficacy of MultiStem for treatment of ischemic stroke. Multistem will be delivered via a single infusion 1-2 days following the ischemic stroke. Multistem is manufactured from human stem cells obtained from adult bone marrow or other non-embryonic tissue sources.

Sponsor: Cytomedix
Phase: Active Phase II clinical trial

Type: Autologous
The goal of this study is to evaluate the safety and efficacy of ALD-401 in treatment of ischemic stroke. For their ALD-401 stem cell therapy, Cytomedix isolates adult stem cells expressing high levels of the enzyme ALDH. The rationale is that ALDH plays a number of important roles in controlling the developmental state of stem cells and that by selecting cells using an intracellular marker they can produce a more heterogeneous cell population with high cellular activity. The cells are collected from the bone marrow of the patient receiving the therapy.

Sponsor: Stemedica
Phase: Recruiting subjects for a Phase II clinical trial

Type: Allogeneic
The purpose of this study is to evaluate the safety and efficacy of using adult bone-marrow derived mesenchymal stem cells in ischemic stroke patients who had their stroke no less than six months prior. The stem cell therapy will be administered to patients intravenously.

Sponsor: SanBio
Phase: Active Phase I/II clinical trial

Type: Allogeneic
This study will evaluate the safety and efficacy of SanBio’s stem cell product SB623 for improving stroke symptoms. SB623 consists of cells derived from bone marrow stromal cells from adult donors. “SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.” In February, SanBio released initial study data.

Dilated Cardiomyopathy

Dilated cardiomyopathy is the third most common cause of heart failure and the number one cause of heart transplantation. Dilated cardiomyopathy is a disease of the heart where the heart becomes weakened and enlarged and no longer pumps blood effectively, eventually leading to heart failure. It is the most common form of non-ischemic cardiomyopathy.

Clinical Trials for Dilated Cardiomyopathy

Sponsor: Aastrom
Phase: Recruiting subjects for a Phase II clinical trial

Type: Autologous
Aastrom is conducting this trial of their Ixmyelocel-T for treatment of heart failure due to ischemic dilated cardiomyopathy. Aastrom manufactures its autologous stem cell product by taking a bone marrow sample from the patient, then isolating and expanding primarily CD90+ mesenchymal cells, CD14+ monocytes and alternatively activated macrophages. The cells are then delivered back to the patient through transendocardial catheter-based injections. Culture and expansion of the cells takes 12 days and administration to patient happens within 3 days of manufacture.

Intermittent Claudication

Intermittent Claudication is a term to describe pain symptoms caused by peripheral artery disease. Peripheral artery disease results in the narrowing of arteries in the legs, which reduces the blood supply. The reduction of blood supply causes pain symptoms.

Clinical Trials for Intermittent Claudication

Sponsor: Pluristem
Phase: Recruiting subjects for a Phase II clinical trial

Type: Allogeneic
This study will evaluate the safety and efficacy of using intramuscular PLX-PAD stem cell therapy injections for treatment of intermittent claudication. PLX-PAD is an allogeneic cell therapy is composed of mesenchymal-like adherent stromal cells derived from full term human placentas. After collection, the cells are then expanded and can be stored for therapeutic use.

I hope that this review has been useful in identifying candidate stem cell therapies for cardiovascular disease. Please comment on which do you think is the most promising? Which would be the most significant?

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