Brandon's Clinical Trial Experience: IBD & Stem Cells

In November of 2014, an enormously painful half-dollar sized perianal abscess took me by surprise. At the time, I had no idea what an abscess was, or where the perianal region was, so I went to my internist (internal medicine specialist) to learn more. (For readers who don’t know, a perianal abscess is when a collection of pus develops near the anus). He directed me to a colorectal surgeon, who insisted that we immediately cut and drain the abscess.  

After two surgical attempts, he surrendered to the uncontrollable buildup of fluid, and passed me along to another surgeon.  

This new surgeon was more tactful in his approach, but he was fighting a harder battle. The abscess had grown into abscesses, that manifested into a intersphincteric fistula. After four more surgical cut and drain attempts, he could no longer cut because the skin was too raw. By July, I had two wounds underneath my scrotum about 1½  inches in length and about ⅜  of an inch deep.

The next option presented was an ileostomy, in which a stoma is opened, and a bag is placed over the stoma to collect waste products that usually pass through the colon. 

The decision was nuclear, but I had the procedure performed.  

The ileostomy failed, causing massive blockages inside of my small bowel. This complication led to many emergency hospital visits and the use of an NG tube. After even more complications, an ileostomy revision was performed in which I was admitted into the hospital for twenty-three nights.

Brandon 2

I asked “When is this going to end?” The answer I was given changed my life forever.

After my discharge, I was introduced to the head GI at the University of Michigan and he put me on Remicade and Imuran, hoping to heal my fistulas. At this point I had also been introduced to a highly regarded GI at The Mayo Clinic in Rochester, MN.  She has written many influential papers on clinical practice for IBD and a book on patient management in IBD. I was also introduced to another surgeon who would manage my surgical treatment. For the next eight months I visited Mayo Clinic dozens of times in hopes that my fistulas were healing. Progress was checked through a Pelvic MRI conducted at each visit. The MRI’s continued to show no improvement.  

After more surgeries for anal fissures and continued pain at the fistula/seton drain sites, I asked “When is this going to end?”  The answer I was given changed my life forever.  

I was told that complex perianal fistula (cpf) healing isn’t measured in days, weeks, or months, but, rather years.  Refusing to accept this answer, I went home that evening and went onto clinicaltrials.gov in search of something that could accelerate my healing.  I found numerous trials around the world for cpf’s and started reading up on the studies.  

There were a lot of elements to weigh before making my decision. Some trials were higher risk with a higher reward, and some lower risk with a lower reward.

The trial I found most interesting was a study on the efficacy of a stem cell procedure being performed at Hospital Universitario Fundación Jiménez Díaz in Madrid, Spain. The two leading doctors behind the study had excellent credentials (one of the surgeons completed her fellowship at Mayo Clinic in Minnesota). I spoke to several trusted members of my care team to validate the high standing reputation of the institution, and I set out to  make contact with the study coordinators.

I first emailed the author of the synopsis I had read online, who emailed back almost immediately, giving me contact information for the head researchers. I emailed them explaining my condition, my research on their trial, and my eagerness to fly to Spain for treatment (also pointing out that I was a patient at Mayo, which I thought couldn’t hurt). Again, I almost instantly received a response back. The next steps included formalities, like sending them some of my medical information so they could validate my condition. After a few weeks of back and forth I was accepted as a patient, however, since only European Union citizens technically qualify for the study, I would have to pay cash to receive the treatment.

All that was left to do was to seek final approval from the quarterbacks of my care team, aka my doctors at Mayo. Proving the efficacy of the treatment took two visits to the hospital spread over the course of  six months, in which I shared all the trial information with my GI and surgeon.  

If they had any reservations about the treatment, I was prepared to follow their advice and forgo participating. They could not have been more open, excited, and encouraging for me to try this option. In fact, my GI had just sent another patient to this group for treatment earlier in the year. (Due to rules and regulations, she could not inform me of this trial which is a whole other matter.) Nevertheless, I was booked to go to Spain in late September of 2016.  

All that was left to do was to seek final approval from the quarterbacks of my care team, aka my doctors at Mayo.

My experience in the European medical system was fascinating. It was thrilling to experience the different approaches to testing and meetings observed in Spain -- some for the better, others for the worse. I went straight to the front of every line, as I was considered a “private” patient instead of a “public” patient (because of the cash) and was given an itinerary of preliminary exams and meetings before the procedure. The hospital facility was beautiful and absurdly clean. I immediately felt a sense of comfort at how sterile the environment.

Another unique thing about Spain hospitals was the dress code, best described as business casual. Many female doctors walked around in blouses, jeans, and open toe shoes, while the men were dressed in sharp suites and ties. As an added bonus to my trip, the hospital cafeteria had better food and coffee than most restaurants here! After some shopping and sightseeing, I was ready for my procedure.  

First, I was to have liposuction performed to extract the adipose tissue to collect cells for replication. This happened first thing in the morning, and I was put under general anesthesia while the plastic surgeon performed the procedure. The surgical room was very sterile, and had all of the modern equipment you would find in US hospitals. 

I woke up to my stem cell surgeon running over in excitement! He was holding a small vial containing the five million stem cells collected.  He was so animated it seemed as if this was the first time he was going to perform the procedure. To see the smartest and most experienced person in the room respond with such enthusiasm elated me. I was relieved that we had been able to culture the cells successfully. It was truly a special moment. A few hours after the liposuction, the surgeons injected four million stem cells into the branch fistula and one million into the main trunk.

To see the smartest and most experienced person in the room respond with such enthusiasm elated me.

I was back home in the USA eight weeks later, visiting Mayo Clinic to see the results. My GI and surgeon were anxious to examine me, so they did so together.  

With results from my MRI taken earlier in the day, they concluded that the results revealed a closed fistula at the branch -- the stem cell treatment worked!  

I went back to Spain in April of 2017 for my second treatment, which consisted of placing about forty-five million cells into the remaining fistula. I did not have liposuction performed this time around, as they were able to culture enough cells from the first procedure to produce the needed amount. After returning to the states, I had a few visits back to Mayo without a clear result, waiting to see if the stem cells worked. Finally in July, it was concluded that my fistulas were officially healed! This result gave me the opportunity to get my ileostomy removed on November 8th and I haven’t looked back since.

With results from my MRI taken earlier in the day, they concluded that the results revealed a closed fistula at the branch -- the stem cell treatment worked!

Happy Brandon

I owe my successful recovery  to my family’s unwavering commitment to my health, my team of doctors who never gave up on me no matter how many times I asked them to throw in the towel and make my ostomy permanent, and of course, I must give credit to myself -- the patient.

I don’t say that in a narcissistic way (well maybe a little). But, I fought hard, did my research, asked the right questions, educated myself to question how I was being medically and surgically managed, and I never gave up hope.

If you want to get healthy, you must believe that there is light at the end of the tunnel no matter how dark, cold, and damp that tunnel gets. I am uncertain if my disease will ever resurface, however, if it does…I AM READY!                   

I fought hard, did my research, asked the right questions, educated myself to question how I was being medically and surgically managed, and I never gave up hope.

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Brandon is a Breakthrough Crew Member and proud IBD patient advocate.