A stem cell study for patients with Heart Failure-DREAM_HF
Brief Description Of Study
This is a study of an experimental study product cells called rexlemestrocel-L, which consists of Mesenchymal Precursor Cells (or MPCs). These cells are special cells that were obtained from the bone marrow of a healthy person or donor who donated bone marrow for the purpose of this study. The donor was tested carefully for many diseases to minimize the possibility that a disease would be passed on to you, the recipient. The cells were isolated from the healthy person’s bone marrow, further purified and then grown outside the donor’s body in order to increase the number of cells. The final purified cells are then stored in a frozen sterile container until they are used for injection. The cells will be thawed and then warmed to room temperature before they are used. “Experimental” means that the study product cells are currently being tested and is not approved by the competent health authorities. The purpose of this study is to determine if the injection of the cells into your heart muscle with a specific type of needle can help restore heart muscle function.
Detailed Study Description
The study comprises 3 main time periods: 1) screening period at the recruiting Heart Failure clinic at Penn Presbyterian Medical Center (PPMC); 2) study intervention (hospitalization for cardiac catheterization (with or without cardiac mapping and cell delivery)) at PPMC (the Cell Injection center); and 3) a follow-up period that includes safety and efficacy evaluations until the end of the study (estimated period is up to 60 months) at the Heart Failure clinic at PPMC and/or at Penn Cardiology clinic in Cherry Hill, NJ. If you decide to take part in this study, you will first sign this Subject Informed Consent Form before any study-related procedures are performed. Thereafter, you will have a Screening Visit to see if you qualify to receive the study product cells. If you qualify and wish to continue, you will be randomly assigned (by chance) to 1 of 2 study groups: (1) Treatment Group administering rexlemestrocel-L (or the MPCs) or (2) Control Group which will receive standard of care for heart failure, but will undergo a partial procedure and will not receive rexlemestrocel-L. You will have an equal chance of being in either of the study groups, much like tossing of a coin. The study intervention (hospitalization for index cardiac catheterization (with or without intracardiac mapping and cell delivery)) will occur at PPMC (a cell injection center). Prior to the initiation of any procedures, the cell injection center will ensure you have signed this Subject Informed Consent Form. If assigned to the Treatment Group, approximately 15 to 20 regions of your heart muscle will be injected with the study product cells using the MyoStar catheter. The areas of the heart to be injected will be identified by your study doctor using the NOGA mapping system and ventriculography. The NOGA system uses measurement of the electrical voltage in areas of the heart muscle to determine if the muscle is suitable for the injection. Ventriculography is a standard procedure in which a contrast dye is injected to the heart left chamber to demonstrate its shape and size. If you are assigned to the Control Group, you will undergo a sham procedure in which a catheterization and ventriculography (the same as was described in the treatment group) will be performed where the study doctor will simulate injection of the study product cells into the heart muscle; however, nothing will be injected and you will not receive the study product cells. You will continue to receive your usual medicines for the treatment of heart failure regardless of which treatment group you are assigned to. The study doctor may adjust your medicines as needed during the study. All patients (in both control or treatment groups) that participate in the study will have a catheter placed into the femoral artery in the groin. A catheter will be threaded up along your aorta (the main artery that delivers blood from the heart) and into the inside of the heart. A special picture will be obtained, called a ventriculogram, using IV contrast (i.e., dye). The injection procedure will be performed by a study doctor specially trained in this procedure. During the injection procedure, you may receive a sedative medication and may be given a headset to listen to some music. The study doctor will announce each injection whether you are receiving the study product cells or not. If you are to receive the study product cells, you will receive up to 20 injections of the study product cells into your heart during this procedure. If you are not assigned to receive the study product cells, you will not receive any injections into your heart but will still hear the study doctor announce each injection. This way you will not know if you received the study product cells or not. Neither you nor the study doctor or study staff that perform the study procedures during the follow up visits will know which study group you were assigned to. This is called blinding the study and is done to avoid any bias in reporting the results or outcome. In this study the doctors and staff in the hospital where the procedure is performed will know which study group you were assigned to (i.e. they will not be blinded) however after your discharge from the site other study staff will perform the follow up and they would be blinded. However, the study doctor can get this information in case of an emergency.