Throne has just received some incredible, long-awaited news that I have the great pleasure of sharing with you.
The United States FDA has just approved Stem Cell Educator Therapy to treat severe COVID-19 in a new phase II clinical trial. This is the 3rd FDA phase II approval in addition to type 1 diabetes and alopecia areata.
COVID-19 has proved fatal to countless people with a compromised immune system. Similar to the principle mechanisms in treating autoimmune diseases, Stem Cell Educator Therapy aims to reset and strengthen the compromised immune systems and thereby reducing the high mortality rate among severe COVID-19 patients.
This new development holds significance for multiple reasons:
This new IND approval will allow Throne to treat severe COVID-19 patients. This is significant because currently there are no effective therapies for rescuing severe patients. Due to this, there have been increasingly high mortality rates among severe COVID-19 patients. This clinical trial will provide Throne the opportunity to significantly reduce mortality rates.
The infection of SARS-CoV-2 virus behind the COVID-19 pandemic involves multiple immune cells including T cells, B cells, monocytes, and macrophages. Conveniently, Stem Cell Educator Therapy has demonstrated its ability to correct multiple immune dysfunctions among these immune cells. In light of this, the new clinical trial will prove very effective in correcting the systemic inflammatory responses and their functional defects among COVID-19 patients.
The FDA has approved this clinical trial to use a closed-loop system. This clinical technique adds to Throne’s therapeutic capabilities in administering Stem Cell Educator Therapy by a patient’s bedside. This was previously approved for an open-loop system that required offsite Education of the patient’s immune cells.
Most notably, the success of this clinical trial will demonstrate the ability for Stem Cell Educator Therapy to treat infectious diseases. This opens up new therapeutic fields and commercial markets beyond diabetes and autoimmune diseases.
While the logistics of this exciting research opportunity are still to be determined, we are very hopeful and excited for what the future holds as we proceed towards a new and healthy normal!