About the DREAM HF-1 Clinical Trial
Why should you consider
participation in this trial?
This clinical trial involves patients with advanced chronic heart failure (CHF). It is called DREAM HF-1, and is sponsored by Mesoblast Inc., a global leader and pioneer in regenerative medicines using cell-based therapies.
The investigational product in the DREAM HF-1 clinical trial consists of Mesenchymal Precursor Cells (or MPCs), a type of investigational regenerative medicine that is aimed at repairing damaged heart tissue and restoring heart function.
DREAM HF-1 is a late stage clinical trial, also referred to as a Phase III clinical trial. This trial is specifically for patients with advanced chronic heart failure (CHF). As a Phase III trial, prior studies have been conducted using MPCs in patients with advanced chronic heart failure (CHF). The results of prior animal and human studies that have been published in medical journals suggest that MPCs may repair damaged heart tissue and help to restore heart pump function. The hope is that the DREAM HF-1 trial will demonstrate that MPCs when administered to patients with advanced chronic heart failure (CHF) will result in a decrease in heart failure-related hospitalizations, delay or prevention of heart transplantation and/or left ventricular assist device (LVAD) implantation, and decrease in cardiac-related deaths.
For more information about this investigational regenerative medicine, visit the About MPCs page on this website.
What are the potential benefits of participation?
The potential benefits of enrolling
in the DREAM HF-1 clinical trial:
The DREAM HF-1 Patient Journey
- Learn about the DREAM HF-1 trial from this Website
- Review some of the important entry criteria for this study
- Take the online DREAM HF-1 questionnaire
- Identify a participating DREAM HF-1 clinical trial center most convenient for you
- Agree to have your questionnaire sent to the DREAM HF-1 clinical trial center that is most convenient for you
What DREAM HF-1 trial procedures will be conducted at
the Clinical Trial Centers?
Please click on each step below
There are several pathways that you can use to inquire about your potential eligibility to participate in a clinical trial. Typically, this includes being evaluated (i.e., pre-screened) to determine if you potentially meet some of the major eligibility requirements in order to then undergo more extensive screening for the trial. To determine your potential eligibility to be screened for the DREAM HF-1 trial, you may:
- Contact your treating doctor if they are participating as a study doctor in the DREAM HF-1 clinical trial,
- Contact a participating DREAM HF-1 clinical trial center.
To determine if you are an eligible candidate for DREAM HF-1, you will need to have a comprehensive Screening Visit with a DREAM HF-1 clinical trial doctor and his/her staff.
At the Screening Visit, the trial will be explained to you in detail and you will sign a Subject Informed Consent Form before any trial-related procedures may be performed or personal health information about you is captured. Next, medical examinations, laboratory tests, and diagnostic evaluations will be performed by DREAM HF-1 clinical trial doctors and their staff to determine eligibility for potential enrollment. Upon signing the Consent Form, it may take up to 42 days until the trial-required screening procedures are arranged and performed.
If your clinical trial doctor determines that you meet all eligibility requirements during Screening, and you agree to continue participation, you will have an equal chance of being randomly assigned to one of two groups, the Treatment Group or the Control Group, and you will undergo a cardiac catheterization to view the inside of your heart.
The cardiac catheterization procedure requires an overnight hospital stay for observational purposes at a participating DREAM HF-1 clinical trial center. The procedure is performed by an interventional cardiologist, who is highly specialized in performing these tasks.
- Group 1 (Treatment Group) – If you are assigned to this group, you will receive the investigational product (MPCs) injected into the heart muscle during a cardiac catheterization procedure. Your condition will be monitored by a DREAM HF-1 clinical trial site until your participation in the trial ends, or
- Group 2 (Control Group) – If you are assigned to this group, you will not receive the investigational product (MPCs) during the cardiac catheterization procedure. Your condition will be monitored by a DREAM HF-1 clinical trial site until your participation in the trial ends.
After the one-time cardiac catheterization procedure is completed, followup of a DREAM HF-1 patient is conducted by a heart failure specialist conducting the study.
Follow-up visits and phone calls are conducted to determine your wellbeing and will continue until your participation in the trial ends. These visits and telephone calls involve medical examinations, laboratory tests, and diagnostic evaluations performed by DREAM HF-1 clinical trial staff members and will occur whether or not you received the MPCs.
The follow-up period will continue until the end of the trial for a minimum of 6 months after the trial-required cardiac catheterization procedure.
During the first year of follow-up, you will have 7 study visits to the participating trial center, and 8 telephone calls. After the first year, you will have telephone calls every 2 months and return for a trial visit every 6 months until the study ends.
Although you will see a DREAM HF-1 clinical trial doctor at no cost to you for the clinical trial examinations and procedures through the follow-up period of the study, you will remain under the care of your current doctor(s) for treatment of your chronic heart failure (CHF) and/ or other medical conditions while participating in the DREAM HF-1 trial.