Stem cell therapy: the next wave in regenerative medicine?

All it involved was a quick injection no different, really, than a flu shot.

A few weeks later, Bill Ambrose realized hed become significantly less reliant on taking Aleve for knee pain, and he was re-learning how to walk without shuffling his feet.

Surgery, it turned out, might not be necessary after all.

Last November, Ambrose scheduled knee surgery to alleviate discomfort in his knees caused by what orthopedic doctors called true bone-on-bone at the joint. But for one reason or another, he kept missing pre-surgery and the surgery never happened.

The next month, Ambrose met with Dr. Bill Nolan, of Cherry Street Health Group, to discuss advertising space in the Danvers Herald.

For the purpose of full disclosure, Ambrose is an employee of Gatehouse Media Company, and he works in the advertising department for Wicked Local, the local branch of GHM newspapers.

After Nolans ads ran inthe Jan. 5issue of the Herald, Ambrose said he reached out to Nolan again. This time, for himself.

Nolans practice offered a solution to his knee pain an alternative to knee surgery he had never considered before: stem cell therapy.

Essentially, the solutionCherry StreetHealth Group offered was an injection of amniotic fluid into Ambrose's knee joint. The stem cells and other growth factorsin the fluid would allow for the regeneration of the cartilage at the joint.

I became interested so I decided to go ahead with it, Ambrose said.

He brought in scans to show Nolan, who said, contrary to what orthopedic doctors had told him, he didnt have true bone on bone. There was still a small space between the bones.

I decided to have one leg done and my knee started getting much better, he said.

Satisfied with the results of the first injection, Ambrose decided to get his left knee done in April.

I still experience some pain in [the left knee], but I get up in the morning and theres very little pain at all, he said in an interview a few weeks following the appointment.

The stem cell option

In the U.S., there are three ways that stem cells are used, Nolan said. Theyre either taken from bone marrow, fat cells, or the amniotic membrane of a healthy c-section from a consenting woman.

When stem cellsare injected into the body,they're expected to increase space at the joint, rebuild cartilage, and ultimately, provide more stability in the joint. As many as 570 businesses across the country advertise some kind of stem cell therapy, according to a 2016 paper.

Stem cell therapy is not necessarily a new discovery, but it is relatively recent in the world of regenerative medicine.Stem cells were first used as much as century ago, first for eye procedures and as filler for the spinal cord, according to Regenexx, which claims to have pioneered orthopedic stem cell treatments in 2005.

Adult stem cells are retrieved directly from the patient, either frombone marrow or fat cells,and concentrated beforeits reinjectedinto the patient's site of pain.

In the case of amniotic fluid therapy,amniotic fluid, which contains stem cells and other growth factors, is injected into the site. These cellshave been shown to "expand extensively" and show "high renewal capacity,"according to research published in the National Library of Medicine.

We know that as you age, your stem cell count decreases,Nolan said, explaining the benefit of using cells from the amniotic membrane. We know that when we get it from the amniotic membrane, theres a large amount of stem cells that are present. From the amniotic membrane, there are no antibodies or antigens, so its safe for anyone to get.

At Cherry Street Health Group, theproduct usedis produced by General Surgical and distributed by RegenOMedix, according to Nolan.The product, which is called ReGen Anu RHEO, is American Tissue Bank approved and FDA cleared.

RHEO is marketed as "a human tissue allograft derived from placental tissue; amniotic membrane and amniotic fluid."Its a"powerful combination" of amniotic fluid and mesencymal stem cells, which are known to differentiate into a variety of cell types, according to RegenOMedix.It also contains growth factor proteins andis "rich" in other necessary components for tissue regeneration.

The product is non-steroidal and comes with no side effects, and the company says no adverse events have been recorded using the product.

Nolan said stem cell therapy has been offered as a treatmentat Cherry Street since 2016.

Across the U.S., there are as many as 56 businesses marketing some form of amniotic stem cellsto its consumers, according to the same paper.

At Rush University Medical Center in Chicago, for example, orthopedic surgeon Adam Yanke enrolled one of his patients into an experimental amniotic cell therapy treatment program. The woman, a 65-year-old suffering from osteoarthritis in both knees, told reporters the injections were "by far the most effective pain treatment" she had tried, and so farthat relief has lasted up to a year.

But while the use of amniotic fluid therapyas a regenerative medicine is becoming increasingly popular throughout the U.S.,the use of amniotic stemcellsdoesn't comewithout concern from some within the community.

Dr. Chris Centeno, who specializes in regenerative medicine andthe clinical use of adult stem cells, has blogged numerous times for Regenexx on the "scam" of using amniotic stem cells most recently in sharply worded post on May 22.

"Regrettably, we have an epidemic on our hands that began when sales reps began telling medical providers thattheir dead amniotic and cord tissues had loads of live cells on it," he wrote.

Nolan said he was familiar with Centeno's posts.

"A lot of the stem cell stuff is new," he said. "Some of the products out there ... They were doing testing on them and not finding cells."

Cherry Street Health Group has treatedabout 50patients with this form of regenerative medicine and had significant success, according to Nolan. Although Nolan owns the health group on Cherry Street in Danvers, the stem cell treatments are provided under the medical practice of Dr. Pat Scanlan.

Weve had really, really amazing success, Nolan said. Weve had over 95 percent success of all the patients weve had in the office. Its been a game changer from a practice standpoint.

The "worst thing" that could happen is there might not be any regeneration, he explained.

"You might get pain relief, but no regeneration," Nolan said. "But from what weve seen, there have been no negative side effects."

At Cherry Street, knees are the most commonly treated joints, followed by hips, shoulders and the lower back. The cervical spine is the least common.

"I hesitated on the surgery, and I'm gladI did," Ambrose said. "Even if[the stem cells]don't do any more than what they've done, its been well worth it."

Patients who do present with true bone on bone, however, are not candidates for this form of therapy, Nolan said.

The cost comparison

At Cherry Street Health Group, the cost of the injection comes toroughly $4,000 per knee, a cost that isn't covered by insurance. By comparison, health-care providers often charge insurers more than $18,000 for knee replacement surgeries in the Boston area, according to a report by the Blue Cross and Blue Shield Association.

The report, however, doesn't account for what the patient actually pays.

Nolan said when other factors of post-op are considered time off of work, rehabilitation time and cost the out-of-pocketcost for surgery compared to stem cell treatment is comparable.

"When you really boil it down, it can be the same or, in a lot of cases, a savings," he said.

Ambrose said it "boggles his mind" that more people don't choose this treatment over surgery.

"Why would you spend $40,000 on a car and not want to spend $4,000 on a knee?," he said."Its crazy. Yes, its out of pocket. So what? We buy a lot of stuff we dont need, and then for something like this, something that people, if they do it, theyll be glad they did it. Its just hard to convince them to do it."

In arecent report in STAT news, a health news start up of the Boston Globe, a study of orthopedic procedures in the U.S. suggested an estimated one-third of knee replacement surgeries are inappropriate. More than 640,000 of these surgeries are performed each year, making for a $10 billion dollar industry in knee surgery.

The study said that evidence isn't limited to just knee surgeries.

"There's a lot that needs to change when we look at health care in general,"Nolan said. "It's really no surprise that something like doing this regenerative medicine is going to take time for it to really take off."

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Danvers health group offers alternative solution to surgery - Wicked Local North of Boston