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Stem cell treatments offer hope but no guarantees for Arizona woman

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.

Due to her foot injury, Janelle James stays home most days, kept company only by her cats.
Amanda Morris

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.

 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.