News | Heart Failure | December 07, 2022

BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure

Approval marks second clinical trial approved by FDA this year for Company’s NK1R+ MSC platform

Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial

December 7, 2022 —   BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to initiate a first-in-human Phase I/II clinical trial of its Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure. 

This trial is designed for patients with New York Heart Association Class II and III ischemic heart failure with reduced ejection fraction (ischemic HFrEF) whose own cell composition makes them ineligible for the Company’s Phase III CardiAMP Heart Failure Trial studying autologous cell therapy that has received FDA Breakthrough Device Designation. 

“We intend to provide a complete cell therapy solution for ischemic heart failure patients that encompasses both autologous and ‘off the shelf’ allogeneic cell therapies. Our therapies are synergistic in serving the full patient spectrum, as only about two-thirds of patients are expected to be responders to our autologous therapy,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “We expect to see efficiencies in the upcoming CardiALLO trial for several reasons: we can leverage screening activity from the currently enrolling CardiAMP trial to direct ineligible patients into the CardiALLO trial; our allogeneic cell therapy is already manufactured and ready for use; and it will be delivered with our proprietary delivery system demonstrated in literature to be the safest and most efficient delivery method available today.” 

He added, “We are excited to study the role our allogeneic NK1R+ MSC therapy may play in helping hearts recover from injury as its mechanism of action involves Substance P. This binds to NK1R+ and has been shown to be an important factor in the development of inflammation, which plays a central role in both heart failure and regenerative processes following myocardial injury.” 

For more information: https://www.biocardia.com/ 


Related Content

News | Heart Failure

March 24, 2026 — New research shows that small improvements to sleep, diet quality and physical activity, made in ...

Home March 25, 2026
Home
News | Heart Failure

March 16, 2026 — Cytokinetics has announced four presentations related to Myqorzo (aficamten) at the American College of ...

Home March 16, 2026
Home
Feature | Heart Failure | Rohit Sood, MD, PhD

Cardiovascular disease (CVD) is a serious global health burden that encompasses a broad group of diseases that affect ...

Home February 12, 2026
Home
News | Heart Failure

Feb. 3, 2026 — Bristol Myers Squibb has launched "Change the Target. Change What’s Possible," an educational campaign ...

Home February 03, 2026
Home
News | Heart Failure

Jan. 27, 2026 — A new national study reveals a stark disconnect between Americans’ desire for preventive cardiac ...

Home January 27, 2026
Home
News | Heart Failure

Jan. 6, 2026 — Millions of Americans living with heart failure are not receiving medications that have been proven for ...

Home January 10, 2026
Home
News | Heart Failure

Dec. 16,2025 — The European Society of Cardiology (ESC) has welcomed the adoption of the Safe Hearts Plan, a landmark ...

Home December 23, 2025
Home
News | Heart Failure

Dec. 18, 2025 — Heartflow, Inc., a provider of AI technology for coronary artery disease (CAD), has announced the ...

Home December 22, 2025
Home
News | Heart Failure

Dec. 18, 2025 – Ventric Health, a medtech company enabling early detection of heart failure (HF) in a primary care ...

Home December 18, 2025
Home
News | Heart Failure

Oct. 22, 2025 – Ventric Health, a medtech innovator enabling early detection of heart failure (HF) in a primary care ...

Home October 28, 2025
Home
Subscribe Now