THE MIRACLE STUDY IS OFFICIAL

We have news that has been over a decade in the making and we could not wait another moment to share it with you. The Phase 2 design of the Miracle Study, our mistletoe clinical trial in collaboration with The Johns Hopkins University School of Medicine, has been officially approved by all parties (Researchers and Believe Big). We are overjoyed, we are grateful, and we are ready to move forward.

What Is the Miracle Study?

Our lead investigator at Johns Hopkins, Dr. Yasser Ged, named the study himself:

“The name MIRACLE reflects both the use of mistletoe and the hope of achieving meaningful responses in patients with limited treatment options using a novel combination, with a subtle nod to the idea of a Christmas miracle.”

We could not have said it better ourselves.

Why Phase 2 Matters

Phase 2 trials are a critical step in the clinical validation process. They evaluate both the safety and effectiveness of a therapy in a larger group of patients and represent a major milestone on the path to making mistletoe therapy standard of care in oncology and covered by insurance for every patient who needs it.

The Miracle Study will examine Helixor M, a European mistletoe preparation, in combination with nivolumab, a leading immunotherapy drug, for patients with metastatic kidney cancer who have progressed on prior treatments and have limited remaining options.

The trial will begin with a Safety Lead-In, where a small group of patients receive the combination therapy to confirm safety and determine the right dose, before expanding to a larger cohort to evaluate how effectively the combination produces measurable tumor responses.

The scientific hope at the heart of this study is that mistletoe’s immunomodulatory properties may actually help restore the immune system’s sensitivity to immunotherapy in patients whose cancer has stopped responding to it. This is a genuinely novel and exciting direction for cancer research.

What Happens Next

With all parties having approved the study design, the Miracle Study now moves to the CRC, the Clinical Research Committee at Johns Hopkins, for institutional review. From there it will be submitted to the IRB, the Institutional Review Board, an independent committee of physicians, researchers, and community members whose role is to protect the rights, safety, and wellbeing of every research participant.

Once both approvals are received, we will be ready to begin recruiting patients. That day cannot come soon enough.

A Gift That Will Change Everything

This trial would not be possible without an extraordinary donor who came to us this past February and said simply that they did not want patients to wait any longer. This remarkable individual provided one million dollars to fully fund the Miracle Study. While they wish to remain anonymous, their generosity will impact patients for generations to come.

We are humbled. We are grateful. And we are in awe of what God is doing through this community.

This Milestone Belongs to You Too

To every person who has prayed for this work, given toward it, shared our story, or simply believed in this mission alongside us, please hear this: you are part of the Miracle Study. This milestone belongs to you too.

We believe miracles are coming. And we are so grateful to be walking this journey with you.