The Miami Project Human Trials Have Begun!

By Maryangela @maryangelav

I wanted to share this letter that Ross just received today from Nick and Marc Buoniconti regarding the first transplantation of the Schwann cells in a human! This is HUGE news for people with SCI. A cure is not too far in the horizon!

WE’VE BEGUN

Dear Friend:

This has been one of the most exciting days ever at The Miami Project and The Buoniconti Fund! As one of The Miami Project’s biggest supporters, I wanted you to be one of the first to know that Miami Project doctors and scientists have performed the first ever FDA approved Schwann cell transplantation in an individual with a new spinal cord injury.

The transplantation procedure was conducted by Drs. Allan Levi and Jim Guest. The participant had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells approximately 4 weeks post-injury. There have been no adverse events and the team is moving forward with the trial. The procedure is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.

“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. The trial and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said Dr. Barth Green, Co-Founder.

“The Miami Project team includes hundreds of scientists, clinicians, and technicians who have joined hands to make the ‘impossible possible’, for which this trial is a key goal and dream now being realized. This achievement reaffirms that the tens of millions of dollars and the incalculable work hours were well invested in this first of a kind human Schwann cell project.”

Led by Miami Project Scientific Director Dr. Dalton Dietrich, the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial.

“As a basic scientist, the hope is always to increase knowledge and discovery. Not every day are you able to see that translated into the clinical realm with the hopes of bettering the lives of those suffering, so this Phase I clinical trial is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries,” said Dr. Dietrich.

Because of YOUR support and the dedication of our scientists and doctors, a cure for paralysis is on the horizon. No longer are we just talking about cells in petri dishes with the hopes that some day in the distant future they could be translated into a possible new therapy. Today, we are actually operating on people and testing the safety of Schwann cells in people with a spinal cord injury.

This is such an exciting time at The Miami Project and I hope we can count on your continued support. Thank you for believing in us.

Sincerely,

Nick Buoniconti
Marc Buoniconti