Commitment to Research

BCDA-01: CardiAMP Heart Failure Trial

About 5.7 million Americans are living with heart failure today, with about half a million more diagnosed each year. The CardiAMP Heart Failure Trial is studying an investigational stem cell-based therapy for heart failure that develops after a heart attack. The therapy takes a personalized and minimally-invasive approach to the use
of a patient’s own cells in the treatment of ischemic heart failure, and is designed to stimulate the body’s natural healing response.

CardiAMP Heart Failure Trial Study Design

The CardiAMP heart failure study is enrolling up to 260 patients at 40 medical centers throughout the United States. The study participants will be randomly placed into one of two groups, a treatment and a sham control group. Neither the patient nor the researcher will know who will be receiving the CardiAMP cell therapy and
who will be receiving the sham treatment. Both groups will be closely monitored throughout the study by a team of physicians and continue to be treated with standard of care medical treatments. 

Are you experiencing one or more of the following symptoms? If so, you may be suffering from heart failure.

  • Shortness of breath, especially when lying down or during exercise
  • Fatigue
  • Coughing or wheezing, especially when exercising or lying down
  • Fluid build-up causing swelling in feet, ankles, and legs

If you are experiencing one or more of these symptoms, are between the ages of 21 and 90, have been diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack, and have a Left Ventricular Ejection Fraction of the heart between 20% and 40%, you may qualify to participate in the study.

To learn more, visit www.clinicaltrials.gov/ct2/show/NCT02438306

SEE IF YOU QUALIFY

BCDA-02: CardiAMP Chronic Myocardial Ischemia Trial

It is estimated that between 600,000 to 1.8 million patients suffer from refractory angina, with approximately 75,000 new cases diagnosed each year. Refractory Angina is a chronic condition,  in the setting of coronary artery disease, that  is characterized by significant debilitating chest pain that greatly reduces quality of life.

The CardiAMP Chronic Myocardial Ischemia Trial will study an investigational stem cell-based therapy that takes a personalized and minimally-invasive approach to the use of a patient’s own cells in the treatment of chronic myocardial ischemia. Similar to BCDA-01: CardiAMP Heart Failure Trial, the therapy is designed to stimulate the body’s natural healing response.

CardiAMP Chronic Myocardial Ischemia Study Design

The CardiAMP Chronic Myocardial Ischemia study will enroll up to 343 patients at 40 medical centers throughout the United States. The study participants will be randomly placed into one of two groups, a treatment and a sham control group. Neither the patient nor the researcher will know who will be receiving the CardiAMP cell therapy and
who will be receiving the sham treatment. Both groups will be closely monitored throughout the study by a team of physicians and continue to be treated with standard of care medical treatments. 

To learn more, visit www.clinicaltrials.gov/ct2/show/NCT03455725


BCDA-03: CardiALLO for Ischemic Heart Failure

Like BCDA-01: CardiAMP Heart Failure Trial, the intent of the CardiALLO Heart Failure Trial will be to study an investigational stem cell-based therapy for heart failure that develops after a heart attack. Where the CardiAMP Cell Therapy System uses a patient’s own cells, the CardiALLO Cell Therapy System will use bone marrow-derived mesenchymal stem cells from a universal donor that have been developed in the lab. Using donor stem cells, eliminates the need for a bone marrow harvest from the patient and provides an alternative therapy option for patients who have been excluded from participating in BCDA-01: CardiAMP Heart Failure Trial as a result of their inability to meet the pre-procedure cell potency assay screening requirements.

News


Have questions?
CALL US NOW
: (800) 624-1179
Have questions?
EMAIL US NOW
: info@biocardia.com

biocardia takes a new and comprehensive
approach to heart failure

By introducing patient screening and highly-efficient delivery to stem cell therapy, the company seeks to increase the likelihood of treatment success, enabling more patients to return to the things they love.