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

#breakingnews The U.S. Food and Drug Administration (FDA) just granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. It is the first vaccine to be fully approved by the FDA, and experts say it is expected to open the door for further vaccine mandates.

Getty Images

News | Coronavirus (COVID-19) | August 23, 2021
August 23, 2021 — The U.S.
The American Heart Association announced its support this week for the CDC and FDA recommendation that immuno-compromised patients should receive a third dose of the Pfizer or Moderna COVID vaccines. Getty Images #AHA #coronavirus #COVID19

The American Heart Association announced its support this week for the CDC and FDA recommendation that immuno-compormised patients should receive a third dose of the Pfizer or Moderna COVID vaccines. Getty Images

News | Coronavirus (COVID-19) | August 18, 2021 | By Dave Fornell, Editor
August 18, 2021 — The U.S.
In an effort to contain COVID-19 and the new rapid spread of the delta virus across the U.S., a coalition of 10 cardiovascular societies issued a statement of support for healthcare systems requiring COVID-19 vaccines for its employees. ACC, HRS, ASNC, SCMR, SCCT, ASE, HFSA, STS, SCAI.

In an effort to contain COVID-19 and the new rapid spread of the delta virus across the U.S., a coalition of 10 cardiovascular societies issued a statement of support for healthcare systems requiring COVID-19 vaccines for its employees. 

Feature | Coronavirus (COVID-19) | July 30, 2021 | By Dave Fornell, Editor
July 30, 2021 — A coalition of 10 U.S.-based cardiovascular societies have issued a statement today in support of all
AHA president says COVID has a direct impact on the heart and preventive measures for heart disease largely went out the window during the pandemic

Getty Images

News | Coronavirus (COVID-19) | July 26, 2021
July 26, 2021 — Heart disease and stroke continue to kill more people in the U.S.
A new study with data from more than 10,000 COVID patients confirmed that patients taking statin medications had a 41 percent lower risk of in-hospital death from COVID-19.

A new study with data from more than 10,000 COVID patients confirmed that patients taking statin medications had a 41 percent lower risk of in-hospital death from COVID-19. Researchers believe statins, which attach to the ACE2 receptors, may block the virus from attaching to these same receptors. 

News | Coronavirus (COVID-19) | July 21, 2021
July 21, 2021 — In a new study from University of California San Diego School of Medicine, researchers have confirmed
New trial results from the international RAPID Trial show that administering a full dose of a standard blood thinner early to moderately ill hospitalized patients with COVID-19 could halt the thrombo-inflammation process and reduce the risk of severe disease and death. How to anticoagulate COVID patients. How to prevent thrombus in COVID patients.

New trial results from the international RAPID Trial show that administering a full dose of a standard blood thinner early to moderately ill hospitalized patients with COVID-19 could halt the thrombo-inflammation process and reduce the risk of severe disease and death. Getty Images
 

Feature | Coronavirus (COVID-19) | July 15, 2021
July 15, 2021 — COVID-19 is m
Diluting of a blood sample for real-time deformability cytometry testing. Researchers at the Max-Planck-Zentrum für Physik und Medizin in Erlangen. Germany, were able to show for the first time COVID-19 significantly changes the size and stiffness of red and white blood cells, sometimes over months. From the study How a COVID-19 Infection Changes Blood Cells in the Long Run. Reasons for long COVID.

Diluting of a blood sample for real-time deformability cytometry testing. Researchers at the Max-Planck-Zentrum für Physik und Medizin in Erlangen. Germany, were able to show for the first time COVID-19 significantly changes the size and stiffness of red and white blood cells, sometimes over months.

News | Coronavirus (COVID-19) | July 15, 2021
July 15, 2021 — Using real-time deformability cytometry, researchers at the...
Researchers analyzing surveillance data on 518 children and adolescents with MIS-C who were admitted to U.S. hospitals in 2020 fopiund those treated with intravenous immune globulin (IVIG) plus glucocorticoids had a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. Left photo Getty Images, right photo Nemours Children’s Health System.

Researchers analyzing surveillance data on 518 children and adolescents with MIS-C who were admitted to U.S. hospitals in 2020 fopiund those treated with intravenous immune globulin (IVIG) plus glucocorticoids had a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. Left photo Getty Images, right photo Nemours Children’s Health System.

News | Coronavirus (COVID-19) | June 28, 2021
June 28, 2021 - A recent analysis found that children and adolescents with multisystem inflammatory syndrome in child
The U.S. Food and Drug Administration (FDA) announced June 25 it has added a warning on the Moderna and Pfizer COVID-19 messenger RNA (mRNA) vaccine fact sheets to explain they may cause myocarditis in rare cases as a side effect. The agency said the side effect is very rare and patients generally recover quickly, but it can disportionally affect younger patients in their teens and early 20s. Getty Images

Getty Images

News | Coronavirus (COVID-19) | June 28, 2021 | Dave Fornell, Editor
June 28, 2021 — The U.S.
A small number of patients develop myocarditis after receiving the messenger RNA (mRNA) COVID-19 vaccines from Pfizer and Moderna. This recently raised concerns after numbers for this adverse reaction jumped in April and May, prompting review this week by the Centers for Disease Control and Prevention (CDC) Advisory Committee on the Immunization Practices (ACIP).

A small number of patients develop myocarditis after receiving the messenger RNA (mRNA) COVID-19 vaccines from Pfizer and Moderna. This recently raised concerns after numbers for this adverse reaction jumped in April and May, prompting review this week by the Centers for Disease Control and Prevention (CDC) Advisory Committee on the Immunization Practices (ACIP). Getty Images

Feature | Coronavirus (COVID-19) | June 24, 2021 | By Dave Fornell, Editor
A small number of patients develop inflammation leading to myocarditis after receiving the messenger RNA (mRNA)...