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On December 5, 2021, Mesoblast announced that the latest analysis results of a phase 3 clinical trial showed that patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes and/or myocardial ischemia can recover from mesenchyme Mass stem cell therapy rexlemestrocel-L obtains the greatest therapeutic benefit
Mesenchymal stem cells can promote the regeneration of vascular endothelial cells by secreting growth factors, play an important role in the maintenance, repair and regeneration of blood vessels, and can promote endogenous tissue repair and regulate immune responses
Recently, the US FDA confirmed that the reduction of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) is an acceptable endpoint of clinical significance for patients with chronic HFrEF
▲Mesoblast product pipeline (picture source: Mesoblast company official website)
This additional analysis of the high-risk patient group shows:
During an average follow-up of 30 months, after receiving a single dose of rexlemestrocel-L on the basis of the best standard treatment, the 3-point MACE of all HFrEF patients (n=537) was reduced by 33% (p=0.
In the best standard treatment HFrEF control group (n=276), the 3-point MACE risk of the diabetes and/or myocardial ischemia group (n=192) was 1.
Compared with control patients, rexlemestrocel-L reduced the overall incidence of 3-point MACE in HFrEF patients with diabetes and/or myocardial ischemia by 37% (n=385, p=0.
Based on the positive results obtained, Mesoblast plans to formally submit to the FDA new data analysis of rexlemestrocel-L reducing mortality and irreversible morbidity in HFrEF patients with diabetes and/or myocardial ischemia, in order to reach a potential approval route Unanimous
Reference
[1] Rexlemestrocel-L Shows Greatest Treatment Benefit on Major Adverse Cardiovascular Events in High-Risk Heart Failure Patients With Diabetes and/or Myocardial Ischemia.
