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# FDA Backs CellProthera Cell Therapy Phase 3 Study
- URL: https://www.fdaweb.com/fda-backs-cellprothera-cell-therapy-phase-3-study/
- Published: 2024-08-30T12:00:00.000Z
- Updated: 2026-09-14T14:40:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157690

CellProthera says it has reached “alignment” with FDA on a planned pivotal Phase 3 trial design for its ProtheraCytes cell therapy after completing a recent IND meeting. “Building on a successful Phase 2 trial in the UK and France, CellProthera is moving into the final phase of clinical development for ProtheraCytes, with a trial to take place in the U.S. and Europe,” the company says. “The trial will include a larger number of patients, with two years of long-term follow up expected in patients treated after an acute myocardial infarction (AMI), to monitor the ability of ProtheraCytes to prevent subsequent heart diseases.”

During the meeting, the company says FDA reviewed pre-clinical and clinical data collected by CellProthera to date, as well as the proposed Phase 3 clinical trial design based on feedback from its Phase 2 EXCELLENT study, which was completed earlier this year, the company says. FDA staff agreed, it says, to CellProthera’s plan for a randomized, concurrent-controlled, open-label trial with standard-of-care post-AMI treatment as the control, measured with a composite endpoint based on findings from the Phase 2 trial.

“EXCELLENT demonstrated that ProtheraCytes improved left ventricular (LV) volumes and viability of myocardial segments at six months following treatment, strong and promising signals of the therapy’s efficacy that will be confirmed through long-term follow-up,” CellProthera says. “This will run in parallel with our recently launched PERFECT study, which will provide additional long-term safety and efficacy data by following patients from our Phase 2 study over an additional ten years.”

The company says preventing mortality and hospitalization for heart failure in AMI patients remains a major challenge. ProtheraCytes is described as an autologous cell therapy that has been developed for body regeneration of damaged tissues, including cardiac tissue. “ProtheraCytes differentiate into endothelial cells and release paracrine factors that support angiogenesis and enhance the proliferation of resident cardiomyocytes, thus attenuating adverse remodeling effects,” it says.