Caution: This story contains graphic depictions and descriptions of a wound that was subject to experimental treatment.
Janelle James has been living with an open wound on the bottom of her left foot since March 2017, after an incision from a bone spur surgery never healed.
Four surgeries, numerous treatments and two years later, she said her doctors were at a loss. One discussed the possibility of amputation.
But James didn’t want to give up so easily.
“Some people do live with chronic wounds, but that’s just not acceptable to me,” James said. “You just constantly run that risk of infection and … amputation down the road.”
James, who lives in Gilbert, started calling different wound care doctors to find out what other treatments were available. In April 2019, a fellow church member referred her to Dr. Richard Jacoby, a podiatrist who performs stem cell treatments using cells from birth tissue.
“He told me I would be a good candidate for the treatment and at that time he said he probably could get me healed up in 10 treatments,” James said.
She decided to give it a shot.
Most stem cell treatments are unproven therapies, and a few are approved by the FDA only as treatments for certain blood and immune disorders. There are no other approved uses outside of investigational clinical studies.
But an Arizona Republic investigation found that hundreds of medical professionals in the state are already administering stem cells for treatment without waiting for approval.
The FDA has issued a warning about unapproved treatments, calling them illegal and potentially dangerous. Federal officials gave businesses using stem cells until May 2021 to comply with FDA regulations, register and obtain permission to start clinical trials.
Because her treatments are not approved, they are not covered by insurance, which meant James would have to pay for any treatments out of her own pocket.
James’ family set up a GoFundMe account at the end of October 2019 seeking to raise $15,000.
She said she received her first stem cell injection on Nov. 8, 2019, and was told she would get two more and potentially be done before Thanksgiving.
Arizona woman hopes stem cell treatments heal her foot
Janelle James had been dealing with a wound on the bottom of her left foot for years. Everything she had tried to treat it hadn’t worked. Then she turned to stem cell treatments.
Amanda Morris, Arizona Republic
“The first week there wasn’t as much growth as what he had expected,” James said. “So I kind of said to him, ‘So, I guess we’re not going to be done in three weeks, are we?'”
The following week, James and Jacoby noticed some tissue regrowth at the top of her wound. On Nov. 22, 2019, Jacoby placed a thin membrane of what he said was birth-tissue derived material on top of her wound. The membrane comes from the placenta that surrounds the baby before birth and is obtained during a normal birth, according to Jacoby, who said the membranes have healing properties.
James believed her progress may have been slowed by another health complication: She has rheumatoid arthritis.
Rheumatoid arthritis is an auto-immune disorder that results in painful inflammation and swollen joints. To control it, James usually takes anti-inflammatory medications such as prednisone, Arava and Celebrex.
“I don’t heal really well because of my autoimmune disorder,” she said in an interview, pointing to small unhealed ulcer wounds on her legs.
The drugs she takes to subdue her inflammation also suppress her immune system. She has been on some of these medications for three decades.
She said she was told they could interfere with her stem cell treatment, so before starting the treatment, James had weaned herself off Celebrex and Arava. She was also working on reducing her daily dose of prednisone.
A few days after her second round of injections, James sat at her dining room table, completing a puzzle. When she wanted to get up, she shuffled slowly out of her chair and onto a knee scooter.
“I’ve been really sore and my joints are all swollen and everything hurts because I’ve been off all of my medications for the past couple of weeks,” she said.
Though she’s a social, talkative person, she has been housebound for years, kept company by two ragdoll cats and her husband, Phil. She has trouble going out independently because of the wound, which kept her from putting weight on her left foot.
“It’s been a real challenge for me to be at home by myself all the time and just have my cats here to talk to,” she said. “They’re not very good conversationalists.”
At 59, James still considered herself young. She didn’t want to go through the rest of her life without the use of her left foot.
Despite the pain, James remained upbeat. She was excited to return to the doctor and see whether the second injections had spurred any more tissue growth.
“I’m really curious to see what it did over the weekend, because it does work really fast,” she said.
Two days later, Jacoby unwrapped the dressing on her foot to reveal brain-like flesh with streaks of blood running through. With one outstretched, gloved pinky finger, he pointed at the top of her wound and bent in for a closer look.
“This is about 50% filled in,” he told her. “This is the new budding of the blood vessels coming in.”
After further discussion, he agreed that the next step would be to put another membrane made of what he described as birth-tissue on top of her wound.
“We got a lot of work to do,” he said. “But it looks good.”
James felt encouraged by stories Jacoby told her about how the treatments had worked for other patients, and himself.
Jacoby said he had a herniated disk that wasn’t getting better, despite physical therapy and traditional medicine. So he got a stem cell injection.
“In three days, I was playing tennis and I haven’t taken the Advil or anything in almost three years,” Jacoby said.
“Do I have miracles? Every day. Does it work on everybody? Absolutely not,” he added. “But it’s a very high percentage of patients.”
In November 2019, James seemed hopeful she would see a similar miracle. She wanted to wear shoes again, and more importantly, she wanted to walk again.
Her biggest fear was that she would go through the process, spend all the money, and still have a big open wound in the bottom of her foot.
“All these people are helping me get this treatment, and what if it doesn’t work?” she said. “There really are no guarantees.”
She hoped she’d be healed by Christmas.
Both of James’ feet were swollen.
When she took off her socks, she noticed her skin puffed up above the sock line.
Her shoulders hurt. Her elbows hurt. Every joint hurt.
During the day, she spent a lot of time sleeping. Getting out of bed and moving around was tough. One night, she sat in her living room to watch TV and couldn’t get out of the chair afterward.
She said she received two more of Jacoby’s birth-tissue derived membranes on her wound in the weeks after Thanksgiving, but her rheumatoid arthritis was acting up.
“It’s been a been a rough couple of weeks for me,” she said, after she eased herself into a kitchen chair. “Hopefully if the stem cell works, it’ll be worth it in the end and I’ll be able to go back on my anti-inflammatories when this is healed.”
James was still taking low levels of prednisone, but she started seeing real progress: big blooms of pink tissue. In between check-ups, she kept her foot bandaged at all times to lower the risk of infection, sneaking glances at the wound when she changed the dressing.
She took every precaution as she did so. After snapping on blue medical gloves, she used clean scissors to cut through layers of gauze and medical tape, which she carefully peeled off to reveal her hard-earned progress.
James was unfazed by the exposed wound. She simply squirted a saline solution on it and cleaned it.
“There could be some new skin growing up here,” she said, pointing at the top of the wound as she gently dabbed it with gauze. “I’m just not sure.”
She explained that Jacoby told her to be extremely careful when changing the dressing to avoid disrupting any new skin growth. At her next appointment, Jacoby expected to be able to tell her if her skin had started growing back, she said.
While she wasn’t sure whether skin was growing back, she said she noticed a big improvement in the wound itself.
“It seems like it’s filling in really quickly, which is much better than previous times,” she said.
She still hoped to be healed by Christmas.
Over the holidays, James took a break from treatments.
The good news was her wound was completely filled in with bright pink, smoother looking flesh and was starting to shrink in size.
The bad news was that her rheumatoid arthritis flared up so badly that she needed to go back onto her medications.
The next step was to close the wound with a skin graft. Since James heals slowly due to her rheumatoid arthritis, she didn’t want to make any other incisions to take the skin from another part of her body for the graft.
Instead, she used a product from Scottsdale-based company called MyOwn Skin. The product, made by BioLab Sciences, uses skin and blood samples from a patient to grow more of the patient’s own skin for grafting purposes. In mid-January, James had her skin and blood collected and sent to BioLab Sciences.
A little over a week later, James was smiling, chipper and chatty as she leaned back on the examination table. It was Jan. 24 and she was about to receive her skin graft.
Jacoby slowly stripped off the dressing, revealing the wound, which was rimmed with thick, yellow calloused skin.
“It looks pretty darn good,” he said, poking and prodding at the new flesh. “Amazing, huh?”
Using a scalpel, Jacoby removed some dead skin around the edges of the wound, and cut into the new tissue so that blood rushed forward. He said the blood would help the new skin and the healing process.
Then he switched to tweezers, picked up a paper-thin square of skin no bigger than a standard Post-It note and placed it on top of the wound. He tucked in the new skin along the edges of James’ wound and injected what he said were birth-tissue derived stem cells through the new skin using a syringe.
“This spot, I think, will be the hardest to heal down here,” he said as he stuck the needle into a deep crevasse on the left edge of the wound.
He wrapped the wound and James rolled out of the office on her knee scooter.
She hoped this could be the final step. She found out in late December that her daughter-in-law was expecting a baby in July. The baby would be James’ first grandchild.
She wanted to heal before the baby was born.
James had a scare shortly after her skin graft when she thought she accidentally ripped off the new skin when changing her dressing.
Two days later, she said Jacoby confirmed that the glossy, transparent white film on her wound was her new skin growing, albeit very slowly.
James was back on her rheumatoid arthritis medications, and worried it could be affecting the healing process.
“It does seem like it’s going slow,” she wrote in a text. “I probably will have to drop my prednisone dosage again to speed up healing.”
Jacoby recommended a second graft.
“I personally wanted to wait a little bit longer, but he decided to kind of push the issue,” James recalled.
James’ second skin graft sample was contaminated and couldn’t be used, she said.
The grafts weren’t covered by insurance, but new donations continued to trickle into James’ GoFundMe.
Then, the coronavirus pandemic hit in late March 2020, and Arizona’s governor issued a stay-at-home order.
By March 31, 2020, her wound had shrunk in size, but didn’t have any new skin on top.
“It’s been a little disheartening that I’m still doing this,” she wrote in a text.
Her second skin graft was put on hold.
On April 24, 2020, James said she got her second skin graft.
Then she waited to see if it would work.
By early July, James said she had spent around $10,000 for stem cell treatments and skin grafts. She had more bills on the way.
“I haven’t gotten all of the bills yet. I don’t know exactly how much it’s going to cost,” she said, sitting on her couch.
Her wound still lingered.
The wound shrank in size by about half since November 2019, but James said she was out of money and couldn’t continue with treatments.
“We didn’t really get what we were looking for. … I’m disappointed that I’m still dealing with it and that I’m not healed yet,” she said.
Both James and Jacoby believe the reason her treatment may not have worked as well was because of her rheumatoid arthritis, which causes her body to heal slowly.
“Maybe I just need to wait and let that skin graft continue to work and to do its thing,” James mused in July.
As a religious woman and an optimist, James was trying to have faith and hope that her foot would eventually heal.
She was encouraged that the wound improved, and said she would consider doing more stem cell treatments in the future, even though it is a costly, unproven treatment. She said she knew there weren’t any studies or research about the effectiveness of stem cell treatments on non-healing wounds for patients with rheumatoid arthritis.
But she figured that, despite a lack of evidence, it was worth a shot, especially since she had heard it worked for others.
“I didn’t see any bad side effects from it,” she said. “If I had unlimited cash funds, I would continue on with the stem cell treatment.”
James became a first-time grandmother on July 26, 2020.
She met her new granddaughter two days later.
Jacoby claims to have a high success rate for the treatments he offers, but he didn’t provide any data or specifics on the ratio of that success.
“For the most part, it’s just one injection, and that’s pretty miraculous. We’re not allowed to use the word cure, but the symptoms go away,” Jacoby said.
He doesn’t have data, he said, because it’s expensive and burdensome for doctors and smaller providers to collect.
“Big Pharma wants to take over this industry,” he said. “But they’re not making this. God made this.”
Though the procedures he offers aren’t FDA-approved, Jacoby said he gets his products from an FDA-certified lab. That doesn’t mean they have been proven safe to use for treatment or approved by the FDA.
If administered in an uncontrolled manner, stem cells can be ineffective, researchers say, and the FDA has warned that unapproved products could be dangerous. Lawsuits against stem cell companies have cropped up nationwide, including ones against California-based stem cell manufacturer Liveyon, which the plaintiffs allege sold and distributed stem cell products contaminated with E. coli.
One such plaintiff was an Arizona man who sued Liveyon for negligence after he developed in E. coli infection following a stem cell procedure.
Jacoby acknowledged that there could be risk of product contamination in the stem cell industry as a whole.
“We’re relying on the FDA to inspect those laboratories to make sure that we’re getting the product we think we are,” he said. “But there have been some instances of contaminated material. … That’s why we want the FDA involved in this. We need a regulatory agency to make sure we’re getting what we’re paying for.”
Jacoby did not respond to questions about whether he planned to start using products that have been FDA approved or have otherwise come into compliance with FDA regulations. Those regulations classify stem cells as drugs that need to be proven safe and effective in clinical trials before they can be marketed as a treatment.
It’s unclear how many stem cells are inside the product that Jacoby administers. Jacoby said he gets his stem cell products from multiple labs, including BioLab Sciences, which markets the products as “amniotic liquid allografts” on its website.
BioLab Sciences has not responded to requests for comment.
As the FDA cracks down on unregulated, unapproved stem cell clinics and treatments, University of Minnesota stem cell researcher Leigh Turner said some stem cell treatment providers seem to avoid using the word “stem cell” openly.
Jacoby is no exception. When talking about the procedure to James, he used the words stem cells, but when speaking to The Arizona Republic, he focused on other types of cells found within birth tissue products.
He said the stem cells in the products he uses, otherwise known as mesenchymal stem cells, are not really stem cells. He said they should be called medicinal signaling cells instead.
“They’re highly anti-inflammatory. They work through the immune system and they reduce scar tissue,” he said.
University of Arizona stem cell researcher David Harris said Jacoby is correct that mesenchymal stem cells have anti-inflammatory properties and that they could help the body self-repair.
But while there is some encouraging data to support the ability of mesenchymal stem cells to treat various conditions such as an open wound, Harris said there’s no conclusive scientific proof yet that they work and that studies are still ongoing.
James would like to see more studies and research on stem cells, with the hope that in the future, procedures like hers would be covered by insurance.
“I really do believe that there’s a future for it,” she said.
In early September, James considered the idea of getting more stem cell treatments, which would cost upward of $1,000.
Ultimately, in November, a full year after she started stem cell therapy, James decided to go in a different direction. She had already spent thousands of dollars out of pocket and wanted to try other treatments that would be covered by insurance.
She’s not sure when she’ll be healed.
Independent coverage of bioscience in Arizona is supported by a grant from the Flinn Foundation.