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Clinical development and proof of principle testing of new regenerative vascular endothelial growth factor-D therapy for refractory angina: rationale and design of the phase 2 ReGenHeart trial

Clinical Development of AdVEGF-D Therapy for Refractory Angina

Background

Many patients with coronary artery disease still experience severe chest pain, known as refractory angina, despite existing treatments. A new gene therapy called AdVEGF-D has the potential to help these patients.

About the ReGenHeart Trial

The ReGenHeart trial is a phase 2 study designed to test how safe and effective the AdVEGF-D therapy is for patients with refractory angina. This trial involves:

  • Multiple centers and a randomized design to ensure reliable results.
  • A comparison between those receiving the therapy and those getting a placebo.

Trial Details

Patients will be divided into groups, with a 2:1 ratio of receiving AdVEGF-D to placebo. The main goals of the trial include:

  • Measuring improvements in patients’ walking ability after 6 months.
  • Assessing changes in chest pain symptoms at the same time.

Additional measures after 12 months will look at:

  • Heart blood flow using advanced imaging techniques.
  • Quality of life, use of medications, and rate of serious heart-related events.

Conclusion

This trial will build on earlier positive results, helping to determine if AdVEGF-D therapy is a safe and effective option for patients with severe angina.

Importance of Clinical Trials

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