News | Stem Cell Therapies | August 16, 2017

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

Multi-center randomized trial will assess ability of CardiAMP stem cell therapy system to improve patient response after heart attack through six-minute walking distance improvement

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

August 16, 2017 — BioCardia Inc. recently announced completion of treatment for the 10-patient roll-in cohort for the pivotal Phase III CardiAMP Heart Failure Trial. A pre-specified review of the 30-day outcomes in this cohort by the Data Safety Monitoring Board is anticipated in the third quarter of 2017.

The investigational CardiAMP stem cell therapy system is designed to deliver a high dose of a patient’s own bone marrow cells directly to the region of cardiac dysfunction to stimulate the body’s natural healing mechanism after a heart attack. Patients are selected for the investigational treatment, in part, based on biomarkers in their bone marrow that are anticipated to maximize the potential for patient benefit.

“Leading clinical sites are actively screening patients for the randomized phase of our Phase III trial, and we are onboarding additional clinical sites in the United States,” stated BioCardia Chief Medical Officer Eric Duckers, M.D., Ph.D., FESC. “The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.”

The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at 40 centers nationwide, 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 reaffirms guidance on its IDE submission in calendar year 2017 for a new CardiAMP indication to treat patients post-myocardial infarction. In addition, the company anticipates submitting an investigational new drug (IND) application in calendar year 2018 for CardiALLO cell therapy, which utilizes bone marrow-derived mesenchymal cells from a donor to treat heart failure.

For more information: www.biocardia.com

 

Related Content About Stem Cell Therapies to Restore Heart Function

FDA Says Adult Stem Cell Research Shows Promise

Resurrecting Dead Heart Tissue

Stem Cell Therapy Holds Promise for Treating Most Severe Cases of Angina

3-D Printed Patch Can Help Mend "Broken" Heart

Cardiac Regeneration After MI: Role of the Extracellular Matrix

Post Heart Attack Recovery Not Aided By Stem Cell Injections, But Demonstrates Promise

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init