cytocentric visionaries ry p4Cytocentric Visionaries: Randy Yerden, CEO BioSpherix

Part Four: A Trachea for Hannah

This post contains excerpts from an interview that Dr. Alicia Henn, Chief Scientific Officer of BioSpherix, conducted with Randy Yerden, Founder and CEO of BioSpherix.

In part three of our interview, we discussed how cytocentric principles benefit cell based assays. Today we talk about the incredible experience of participating in groundbreaking surgery to implant a stem-cell bearing manufactured trachea into a toddler. Continue reading to learn how GMP cell therapy for the artificial trachea was performed with our donated Xvivo systems.

Tell us about what it was like to see a patient impacted directly by your technology and to help make history in regenerative medicine.

RY:Frankly, if my career had ended the day after that, I would have been happy.

Hannah Warren was born in Korea without a trachea (windpipe). She was lucky because her doctor recognized the problem and got a tube down through the mess in her congenitally malformed throat and into her lungs. That tube kept her alive, but she would need a real trachea to survive very long.

Her parents searched the world for the best pediatric thoracic surgeon they could find. They found him in a gentleman named Mark Holterman who worked in a Catholic Hospital in Peoria, Illinois. They asked him if he would consider saving their daughter.

He said he could give it a shot, but the only procedure available was to take part of her intestine and put that where her trachea should be, two operations on opposite ends of a tiny body. He said that it was unlikely to succeed and she would go through a long, dreadful recovery if she survived. However, he worked for a hospital known for their charitable work. They might be willing to do this for free.

Hannah’s parents decided not to put Hannah through that, but their hope never dimmed. Months later, they heard a news story about an Italian surgeon who had successfully implanted a man-made trachea into a man with cancer.

Hannah’s parents called this surgeon, Paolo Macchiarini, and asked if he would make a trachea for their baby. He agreed. However, his institution had to charge a lot of money, which they didn’t have, and this wouldn’t be covered by insurance.

At a dead end, Hannah’s parents asked if there was a way that Dr. Macchiarini could do his modern surgery at Dr. Holterman’s charitable hospital. The two doctors agreed and over the course of another year, they got permission from the FDA to do what would be groundbreaking surgery in a child this small.

The only problem was that at the Peoria hospital, they didn’t have a cell culture facility equipped for good manufacturing practices (GMP) to safely seed the new trachea with the baby’s stem cells.

Our company has a system for GMP cell therapy which is mobile and is designed for this type of use. They asked us and we agreed to donate the use of one of our Xvivo systems. We just happened to have the perfect system in our showroom.

This Xvivo system could enclose all the equipment and work surfaces that were needed to grow the stem cells that would be seeded in the artificial trachea. Dr. Macchiarini’s team could work from the outside of the system, through sealed glove-fronts. The cells could grow into the trachea right there inside the system, protected from room air and microbial contamination.

In just six weeks, we disassembled our Xvivo system, moved it from Upstate New York to the surgical suite in Peoria, and had each part of it GMP-tested, validated and ready for operation. To do this in just six weeks was unprecedented. Then we trained Dr. Macchiarini’s team in how to use our system.

They had a dry run before they did the real thing, and produced what appeared to be a very good looking man-made trachea. So the following day, Hannah’s bone marrow was extracted next door in the surgical suite. Then using our system, Dr. Macchiarini’s team got the trachea scaffold seeded with her stem cells.

The cells grew in the trachea structure inside our system for several days and when the trachea was ready, they brought Hannah into the surgical suite again.

Over the course of a nine-hour operation, Drs. Macchiarini, Holterman, and Pearl, the Chief of Pediatric Surgery, opened up the congenital defect area in her throat. Those surgeons stood and worked without a break for nine hours straight.

You know, since then, there have been several attempts to smear Paolo Macchiarini’s name and his reputation. Knowing him personally and having watched him work; I can tell you that that man is a hero. He is truly dedicated to helping people that have no other options.

When the surgeons were ready, they walked the trachea from our system right around the wall into the adjacent surgical suite and implanted into Hannah.

It was a smashing success.

We were invited back out to Peoria about a month later for a press conference. It was absolutely heart breaking as her parents described all that they had gone through. Hannah had never been out of an intensive care unit. She had always had a tube down her throat. Now she could taste foods and make sounds, and her sister finally had someone to play with. I have never seen anything so tear-laden as that press conference. Everyone in the room was crying.

But then what was really cool was that afterward our team was invited to go see Hannah. We saw her through the windows of her hospital suite. She was sitting on her bed with a couple of therapists pointing at things in books. When she saw us, just a bunch of strangers in the window, she ignored her books, ignored her therapists, and gave us the biggest smile. Then she kind of laughed and waved to us.

I tell you, I will never, ever forget that feeling. It was the most awesome thing that I could ever have imagined. My crew felt the same way. Tragically, Hannah passed away from other medical problems later that year, but at least she had that time with a real trachea.

Our products are out there all over the world now; tools being used for clinical trials of wondrous new cell therapies and regenerative medicines. Patients with diabetes, blindness, and cardiac damage have new hope.

I am so proud of our team; proud that we are providing a tool for this industry that is making a difference for patients like Hannah.

This concludes our multi-part interview with BioSpherix Founder and CEO Randy Yerden.

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alicia author iconAbout the Author

Alicia D Henn, PhD, MBA

Alicia Henn has been the Chief Scientific Officer of BioSpherix, Ltd for two years. Previously, she was a researcher at the Center for Biodefense Immune Modeling in Rochester, NY. Alicia obtained her PhD in molecular pharmacology and cancer therapeutics from Roswell Park Cancer Institute in Buffalo, NY and her MBA from the Simon School at University of Rochester in Rochester, NY.