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Learn more about the study below or answer a few questions right now to see if you may be able to participate.
If eligible, you will receive study-related care and an experimental therapy at no cost. All tests and procedures performed as part of the research study, the experimental therapy, and the cost of the administration procedure and hospitalization will be paid for by the sponsor.
Study-related doctor visits will provide you with thorough exams and your care will be carefully monitored throughout the study. Plus, you may be eligible to receive some compensation for travel-related expenses (for example, parking, meals, travel) incurred for coming to your study visits.
Your time is valuable, therefore we appreciate your interest in researching a potential therapy for those suffering from angina caused by coronary artery disease. Our hope is that this research may benefit future patients like you.
The EXACT Trial is being conducted by XyloCor Therapeutics, a company focused on improving the lives of people with cardiovascular disease through a commitment to the science of gene therapy.
About the Study
The purpose of this research is to determine the safety of an experimental drug in human research subjects suffering from angina caused by coronary artery disease who have no other treatment options. This is the first research study in which this drug will be administered to humans. The study drug is designed to promote new blood vessels in the heart, with these new blood vessels bypassing the blockage in your coronary arteries and improving blood flow in your heart.
The study drug is designed to seek out cells in your body and deliver a gene that allows those cells to create more of a protein that naturally exists in your body. This process is called gene transfer. The study drug aims to deliver the gene via an injection to the cells of the heart. This will be done in the operating room by an experienced surgeon.
How Does Gene Therapy Work in This Trial?
The gene therapy product XC001 is an altered adenovirus, refered to as the vector, that includes a gene for human vascular endothelial growth factor or VEGF. The vector cannot reproduce and has been shown to be safe in human studies.
Once the vector is delivered to your heart and makes its way into cells, it breaks up while delivering the gene into the cell nucleus, where your DNA is located.
Your own cell machinery makes VEGF protein and then ships it outside the cell where the protein can help new blood vessels form.
This is expected to bring more blood and oxygen to areas of your heart that need it.
What To Expect
If you decide to take part in this study, you will come to the clinic for 1 to 3 screening visits to complete some examinations, tests and procedures to find out if you can be in the study.
If you are deemed eligible, you will receive 1 of 4 doses of the experimental drug. You will continue taking all of your other medications prescribed by your doctor. Approximately thirty-three (33) participants will take part in this study. All follow-up visits will be scheduled based off the date you received the experimental drug.
Your participation will last up to 13.5 months. During this period, you will be expected to complete a total of 10 study visits: 3 visits during a 50-day screening period, 1 visit during your overnight stay in the hospital (or more depending on your recovery), and 6 follow-up visits over 12 months after your surgery.
Risks and/or negative effects related to the procedures and experimental drug we are studying could happen; with the administration of the experimental drug and with the surgical procedure; with the study drug itself; and during the tests and procedures used to test effectiveness and safety of the experimental drug.
Before you begin the study, the study doctor will meet with you to explain all the details of the clinical trial. They will answer any and all questions you or your family might have.
About Clinical Research
A person who takes part in a research study is called a research subject or research participant. The main goal of a research study is to acquire information to help others in the future. But before a drug can be approved for use by patients, a thorough process of research must be conducted. This includes testing a study drug in clinical trials involving people. Clinical trials are one of the key steps in the research process before a drug can be approved for use by regulatory agencies.
All clinical trials are designed with the safety of the study participants in mind. By law, an independent institutional review board (IRB) must approve the study protocol (or plan) before a study begins. An IRB is a group of people who review research studies to help protect the rights and welfare of research participants. In addition, the team of medical professionals running the trial oversee the health of study participants throughout the trial. Being part of a clinical trial is voluntary. You may change your mind and leave the trial at any time.
What is Angina?
Angina feels like pressure, heaviness, tightness, or pain in the chest. This symptom is caused by obstructive coronary artery disease (CAD). CAD is a chronic disease in which blood flow through the arteries that supply the heart with oxygen-rich blood are blocked. This leads to a restriction of blood supply to the heart and is called ischemia. When blood flow to the heart is limited, the heart cannot get the oxygen and nutrients it needs to work properly.