News | Heart Failure | June 30, 2020

BioCardia Resumes Cases in the CardiAMP Heart Failure Trial

BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era

BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era

June 30, 2020 —  BioCardia, Inc. announced that the company has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida this month. New consents have also taken place at additional centers. 

“We are pleased to be able to resume enrollment at several sites for our lead clinical program and look forward to cases taking place in July and August,” said BioCardia CEO Peter Altman, Ph.D. “As study centers resume elective procedures, we are working closely with our clinical partners to implement new FDA recommendations for clinical trials with respect to COVID-19 in order to minimize the impact on our patients, as well as the trial ahead. COVID-19 has been reported to cause heart damage, and some of our clinical investigators are seeing an increased amount of heart damage in patients who have avoided treatment due to fear of COVID-19 exposure. Our cardiac programs have the potential to help address this growing clinical need and are even more important in the current clinical landscape.”

The CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous bone marrow-derived mononuclear cell formulation designed to stimulate the body’s natural healing response in treating heart failure which develops after a heart attack. The trial is evaluating the cell therapy’s ability to improve patient survival, exercise capacity and quality of life, as well as its safety. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively select patients based on cell potency to maximize the probability of patient benefit.

The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The national co-principal investigators are Amish Raval, M.D., of the University of Wisconsin and Carl Pepine, M.D., of the University of Florida, Gainesville.

In March 2020, the Data Safety Monitoring Board indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 75 patients have been enrolled at 25 active centers. The trial is sponsored, in part, by the Maryland Stem Cell Research Foundation and has reimbursement from the Centers for Medicare and Medicaid Services (CMS). 

For more information: www.biocardia.com

Related CardiAMP Heart Failure Trial content:

How Biotechnology is Impacting the Treatment and Prevention of Heart Disease

CardiAMP Heart Failure Trial Design Presented at Texas Heart Institute Symposium

BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial

 

Related Content

News | Coronavirus (COVID-19)

December 1, 2021 — A small but significant percentage of college athletes with COVID-19 develop myocarditis, a ...

Home December 01, 2021
Home
News | Coronavirus (COVID-19)

November 23, 2021 — The antiplatelet drug class of P2Y12 inhibitors that block the activity of platelets and prevents ...

Home November 23, 2021
Home
News | Coronavirus (COVID-19)

November 19, 2021 — A high dose of a purified omega-3 fatty acid, available by prescription only, was well tolerated ...

Home November 19, 2021
Home
News | Coronavirus (COVID-19)

November 17, 2021 — People in the U.S. who live in socially vulnerable neighborhoods, which includes communities with ...

Home November 17, 2021
Home
News | Coronavirus (COVID-19)

November 9, 2021 — The COVID-19 (SARS-CoV-2) virus does not infect blood vessels, despite the high risk of blood clots ...

Home November 09, 2021
Home
News | Coronavirus (COVID-19)

November 5, 2021 — In the worldwide effort to battle COVID-19 (SARS-CoV-2), researchers have often turned to medications ...

Home November 05, 2021
Home
Feature | Coronavirus (COVID-19)

November 5, 2021 — The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID ...

Home November 05, 2021
Home
Feature | Coronavirus (COVID-19) | By Dave Fornell, DAIC Editor

November 4, 2021 — The Centers for Medicare and Medicaid Services (CMS) today issued an emergency regulation now ...

Home November 04, 2021
Home
News | Coronavirus (COVID-19)

October 15, 2021 — The correlation between poor oral health and COVID-19 (SARS-CoV-2) severity, as well as the ...

Home October 15, 2021
Home
News | Coronavirus (COVID-19)

September 28, 2021 — A research team at the University of Arkansas for Medical Sciences (UAMS) has identified a ...

Home September 28, 2021
Home
Subscribe Now