BioCardia, Inc. [Nasdaq: BCDA], 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.
https://finance.yahoo.com/news/biocardia-announces-fda-approval-ind-120000674.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.