Montgomery family credits Mesenchymal stem cell therapy for son's dramatic improvement

Kristy Heckendorn helps her son Braden, 11, with his homework Thursday, Dec. 7, 2017, in Montgomery. Braden Heckendorn, born right-hand dominant, is having to learn to use his left hand for writing and other functions after a pellet gun projectile to the chest in 2013 sent him into cardiac arrest, resulting in a traumatic brain injury and leaving him legally blind. Ten months after receiving three, intravenous infusions of his mesenchymal stem cells in January 2017, Heckendorn's vision and motor functions have improved. less Kristy Heckendorn helps her son Braden, 11, with his homework Thursday, Dec. 7, 2017, in Montgomery. Braden Heckendorn, born right-hand dominant, is having to learn to use his left hand for writing and other ... more Photo: Jason Fochtman, Staff Photographer Photo: Jason Fochtman, Staff Photographer Image 1 of / 6 Caption Close Montgomery family credits Mesenchymal stem cell therapy for son's dramatic improvement 1 / 6 Back to Gallery

A Montgomery couple believe a type of stem cell treatment administered in Mexico has dramatically improved the effects of their son's traumatic brain injury.

And, they want others to know there is hope through Mesenchymal stem cell therapy, which currently is not allowed to be administered in the United States.

The ordeal started in 2013, when Bruce Heckendorn, a U.S. Army veteran and former Houston firefighter, returned to the United States from combat in Afghanistan with a traumatic brain injury and physical wounds.

However, while recovering, Heckendorn received terrifying news about his son Braden.

Only 7 years old at the time, Braden was setting up targets when a nearby pellet gun went off and shot him in the heart. The youngster went into cardiac arrest almost immediately.

He lost his heartbeat for 22 minutes, suffered a traumatic brain injury from the lack of oxygen needed to keep his brain cells alive and then had a stroke. While he defied the 1 percent survival chance predicted by doctors, the incident robbed the child of his ability to see, walk and talk.

"I used to get so frustrated when I couldn't talk," Braden, now 11, told The Courier Thursday, remembering when he could barely garble three words in 2015.

"I was upset because I knew what I wanted to say and couldn't," said Braden, who still has verbal slurring but now can be understood.

Braden spent five months in the hospital after the shooting incident. He returned home in a wheelchair and was completely dependent on his parents, including his mother Kristy Heckendorn, who stays at home to care for him.

Despite some improvements, Braden hit a wall in therapy.

"He wasn't really getting any better," Kristy said.

After researching online, the Heckendorns learned about a new option: adult Mesenchymal stem cell therapy. The process entails extracting hundreds of millions of Braden's Mesenchymal stem cells from the fat in his abdomen and reinjecting his cells into the body. The Mesenchymal cells have the ability to become different types of cells depending on disease or need. In this case, the therapy would help bypass the damaged brain cells from and bridge the good cells in his brain, his father said said.

The couple reached out to the Houston-based, private biotechnology company Celltex Therapeutics. Celltex stated it is initiating breakthroughs in regenerative medicine by specializing in high-dose adult Mesenchymal stem cell therapy. The company claims there are no side effects or risks to the therapy, which former Texas Gov. Rick Perry received for an ailing back in 2011. After much thought, the family decided to move forward with the treatment.

Once Braden's cells were removed, they were harvested in the Houston laboratory, but not immediately returned to his body. While the FDA allows the laboratory to remove and store the cells, Dr. Stanley Jones, who is the chief medical officer for Celltex Therapeutics, said the FDA considers the infusion of one's own expanded stem cells into the body as the equivalent of administering a drug, which requires a clinical trial. At this time, the FDA does not allow the therapy in the United States.

Lacking the clinical trial and FDA approval, Braden and his family traveled to a Celltex partner in Cancun, Mexico, where he received three infusions in January. The family said they have seen a significant improvement in a short period of time.

"Once he got the stem cell therapy, he progressed quickly," Kristy said. "I think if we hadn't done any of this therapy, I don't think that he would be as advanced as he is right now."

Braden told The Courier he is happy to be able to once again do some of the things he once could before the accident, which his parents attribute to the infusions. The improvement in his vision made it possible to once again read in school and be active in physical education class, the family said. He can even dress himself again, walk and is regaining use in his still-impaired right hand.

But the improvement came at high cost that required the family to make some difficult life-changing decisions. One therapy session alone can cost between $4,000 and $13,000; and it costs another $6,500 to store the cells in a bank. The more infusions, the more likely Braden is to continue to see improvement, but the family believes the thousands of dollars invested in the treatment has helped Braden.

"You'll do whatever it takes for your kids," Kristy said. "We saved and scraped and pinched and we got his first three infusions done and hopefully we will get some more done. … It cost a pretty penny, but it's something we are working toward again."

To support his family through Braden's therapy, Bruce retired from a 22-year military career in 2015 and left a 14-year career with the Houston Fire Department taking on a full-time job at the South Montgomery County Fire Department. He also works part-time at the Magnolia Volunteer Fire Department.

The family said their insurance does not cover the costly therapy. Most of Bruce Heckendorn's firefighting salary goes toward paying for it out of pocket. His wife wrote a local congressman to support allowing the stem cell therapy in the U.S.

"We need it here," Kristy said. "It would be so much more affordable if it was in the United States. We want other people to know, especially with a child with a brain injury, there is hope out there. You have to be an advocate for your child."

Bruce believes stem cell therapy may be misunderstood and insists the treatment can help others who have suffered traumatic brain injuries, including military veterans like him.

"If we could even get it down to the government level for TBI …," he said. "The ironic thing is he was down for 22 minutes - which is the same number of veteran suicides per day. A lot of that is attributed to TBIs not being fixed, corrected or recognized. If you could get some of the perception of stems cells not being cloning and put it in a more positive light, that would be great."

Celltex and the FDA

On Tuesday, Jones said Celltex is now, as of this week, approved to start clinical trials in Cancun for rheumatoid arthritis and osteoarthritis, which as of last week he anticipated was still two years away.

As a 35-year veteran spinal surgeon, Jones described Braden's progress as phenomenal and noted may people have a hard time believing him about the therapy's success. Out of 4,500 therapies, he reported 75 percent major symptom improvement for patients with Parkinson's disease, 79 percent for multiple sclerosis and 92 percent for rheumatoid arthritis.

"They think it is wild exaggeration," he said.

Jones first sought the stem cell treatment in Japan for his own rheumatoid arthritis. After experiencing the success, he wanted the program in the United States where families would not have to travel as far for relief.

"Stem cells can heal better than anything else," Jones said, "which means the body is a better healer of one's own disease than any other drug in the world. I would really love for people to start writing the FDA, their congressman, and make stem cell therapy a commonplace word and therapy so that people have the choice of what kind of medicine they want to take."

"I see really sick people a lot and all that they want is hope …," he added.

The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells, hematopoietic progenitor cells, derived from cord blood, according to the FDA.

While there are some stem cell clinics that exist, they are not using expanded or cultured stem cells like Celltex. Jones said those types of stem cells are not as effective as the high doses of Mesenchymal

The FDA, which targeted Celltex in 2012, launched a crackdown on expanded stem-cell therapy in September 2012. Jones said the company at the time had a different partner and the issue has been resolved.

In November, the FDA released four new guidance documents to serve as a comprehensive regenerative medicine policy framework intended to balance the safety of patients with innovation in medicine.

"The agency is committed to ensuring that patients have access to safe and effective regenerative medicine products, within the framework of FDA regulation. The field of regenerative medicine is rapidly evolving and requires a nimble, flexible approach to help ensure these products are available to patients with serious unmet medical needs," FDA Press Officer Andrea Fischer stated in an email to The Courier. "This modern framework is intended to balance the agency's commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible."

For more information, visit celltexbank.com or fda.gov.