News | Heart Failure | September 25, 2017

CardiAMP Heart Failure Trial Design Presented at Texas Heart Institute Symposium

Phase III multi-center trial will enroll up to 260 patients to assess impact of stem cell therapy treatment for heart failure

CardiAMP Heart Failure Trial Design Presented at Texas Heart Institute Symposium

September 25, 2017 — BioCardia Inc. announced the trial design for its pivotal Phase III CardiAMP Heart Failure Trial was presented during the “Heart Failure: The Big Target for CV Regenerative Therapy State of the Field” session at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine, Sept. 15-16 in Houston. As an invited faculty member for the meeting, Professor of Cardiovascular Medicine at the University of Florida and study co-national principal investigator Carl Pepine, M.D., presented the design.

CardiAMP therapy, an investigational product, takes a personalized and minimally-invasive approach to the use of stem cells for treating heart failure from a heart attack, learning from unsuccessful methods that have come before. By screening for patients with a higher likelihood of benefiting from treatment and delivering a high target dose of 200 million of a patient’s own bone marrow cells directly to injured cardiac tissue using a proprietary delivery system, CardiAMP therapy is designed to stimulate the body’s natural healing response.

The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled clinical study at 40 centers nationwide of up to 260 patients, which includes a 10-patient roll-in cohort. The trial’s primary endpoint is an improvement in six-minute walking distance at 12 months post-treatment. In addition, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events.

The company also announced the launch of a new website designed to support patient recruitment for the CardiAMP Heart Failure Trial. On the site, prospective patients can learn more about heart failure and the CardiAMP cell therapy system, and be screened for participation in the trial.

For more information: www.biocardia.com

Related Content

News | Cardiovascular Clinical Studies

June 24, 2021 — Data captured in American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ...

Home June 24, 2021
Home
News | Cardiovascular Clinical Studies

January 27, 2021 — A New York Institute of Technology research team has secured a five-year $1.8 million grant from the ...

Home January 27, 2021
Home
News | Cardiovascular Clinical Studies

July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to ...

Home July 22, 2020
Home
News | Cardiovascular Clinical Studies

July 1, 2020 — Carag AG announced receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption ...

Home July 01, 2020
Home
News | Cardiovascular Clinical Studies

January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special ...

Home January 20, 2020
Home
News | Cardiovascular Clinical Studies

Environmental and lifestyle issues were popular this year, with pick up from both European Society of Cardiology (ESC) ...

Home December 23, 2019
Home
News | Cardiovascular Clinical Studies

November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have ...

Home November 26, 2019
Home
News | Cardiovascular Clinical Studies

July 10, 2019 — The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During ...

Home July 10, 2019
Home
News | Cardiovascular Clinical Studies

July 3, 2019 — The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to ...

Home July 03, 2019
Home
News | Cardiovascular Clinical Studies

November 19, 2018 — The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent ...

Home November 19, 2018
Home
Subscribe Now