Stem cell therapy, which All Blacks prop Owen Franks used to help fix a damaged shoulder, is raising hopes of a whole range of medical breakthroughs.

But there's a way to go before the medical establishment is convinced.

In late 2017, US Food and Drug Administration (FDA) Commissioner ScottGottliebhad this to say:"We're at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease."

REGEN CELLULAR

Dr Hassan Mubark takes blood from All Blacks prop Owen Franks.

Yet, as an indication of how far there is still to go, the FDA has also warnedpeople in the USagainst "unscrupulous providers" offering stem cell products that were unapproved and unproven.

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"Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases," it said, thenadded: "Stem cells have been called everything from cure-alls to miracle treatments. But don't believe the hype."

Looking at just the area of deteriorating joints, it's easy to see how stem cell therapies, if they deliver on the promise,could make life much better for many people with osteoarthritis who are in pain and have restricted movement.

Last week, Otago University researchers predictedthe number of knee replacement surgeries needed for osteoarthritis would increase from around 5000 a year in 2013 to abut9000 in 2038.

AP

Former Formula One champion Michael Schumacher received devastating head injuries in a ski accident six years ago. Last month it was reported he has undergone stem cell treatment in Paris.

Osteoarthritis is the area where ReGen Cellular,the clinic where Franks had the therapy, has done most of its work in the past two to three years, although ithas recently expanded its services to include a range of diagnosed auto-immune conditions, among them rheumatoid arthritis, multiple sclerosis, and type 1 diabetes.

ReGensaid 55 per cent of its patients were aged over 60, 35 per cent were 40-60 and 10 per cent were sports-based.

Theclinic usesPure Expanded Stem Cell (PESC) therapy, which involves taking 40 grams - about a teaspoon - of fat from around a patient's stomach. Mesenchymal stem cells (MSCs)in that sample are then multiplied in the clinic's Queenstown laboratory for about eight weeks. At the end of that process 100 million to 200 million cells have been produced.

Otago University

Otago University, Christchurch regenerative medicine research team have invented a bio-ink - a gel-like substance mixed with human stem cells - to be used with a bio-printer to make human body parts. Video shows the printer using bio-ink to make a body part.

For the treatment of osteoarthritis, between 50m and 100m stem cells are injected into larger joints, with 25m to 50m into smaller joints. ReGen said the therapy provided immediate pain reduction and increased mobility. MRI scans showed cartilage could and did regenerate.

ReGendescribedMSCs as the cells that "wake up damaged or lazy cells". Slightly more technically, Nature.com said MSCs wereadult stem cells present in multiple tissues, including the umbilical cord, bone marrow and fat.MSCscan self-renew by dividing and can differentiate into multiple tissues including bone, cartilage, muscle and fat cells, and connective tissue.

ReGen director of patient care Marcelle Noble said the clinic believed its treatments, if offered early enough, would save the public health system hundreds of millions of dollars through lessened replacement surgeries, and would save ACC millions of dollars in lengthy rehabilitation programmes.

The treatment for two knees was half the price of one knee replacement surgery within the public health system, she said. ReGen advertises osteoarthritis treatment for a single joint at $12,500 and for two joints at $15,000.

GETTY IMAGES

Former All Black Israel Dagg had stem cell therapy for an injured knee, but in the end had to give the game away because of the injury.

So far mainstream funding hadnot been offered for the therapy, Noble said. But the clinic had a "big breakthrough" earlier this year when two insurers in New Zealand accepted patients'PESC therapy claims. In July, ACC accepted consultation by ReGen's chief medical officer Dr Hassan Mubark.

ReGen only had data for the past five years on the success of its therapy, but the fact patients were returning to have other areas of their body treated was an indication of how people feltthe therapy was improving their quality of life, Noble said.

Globally, "massive" R&D spending was going into stem cell research. More therapies would become available and stem cell treatment would become "commonplace".

At any one time ReGen had 50-75 patients' cells growing in its incubators, Noble said. Of the patients treated, 40 per cent hadailments in therknees, 30 per cent in their hips, 20 per cent in their shoulders. The final 10 per cent were for sports and other issues, including problems with tendons, muscles, cartilage tears, fingers, elbows, ankles and hands.

SUPPLIED

Dr Ron Lopert undergoing part of the PESC treatment.

The first patient to undertake ReGen's PESC therapy was retired GP Dr Ron Lopert, who lives in Tauranga.

For five to 10 years, he had beengetting aches and pains in his hips after playing sport, and the problem was becoming more noticeable, he said. In 2013 he had an x-ray that showed he had moderate to severe osteoarthritis in both hips,more severein his right hip.

He stopped playing all sports and started researching different forms of treatment. Ideally, he wanted to be able to get some of his own cartilage back and reverse the osteoarthritis. It seemedPESCshould do that.

In 2015, aged 61, he had the therapy, with stem cells being injected into each hip joint.Within weeks henoticed an improvement in the range of motion and a decrease in pain, Lopert said.Some of that was just the anti-inflammatory component of stem cell injection, but he thought he also received a longer term benefit from cartilage regeneration.

SUPPLIED

Dr Lopert on his recent travels. He says he has much less hip pain.

He put the success of the procedure at75 per centin terms of symptoms and function, and100 per cent when it came to avoiding invasive surgery."I opted for a much more natural treatment where my own tissue is regenerating, instead of a metal prosthesis," Lopert said.

He was not sure all the improvement came from the stem cell treatment. As well as avoiding overuse of the joints, which meant he hadn't returned to playing sport, he had also switched to an anti-inflammatory diet.

His left hip continued to have hardly any symptomsbut he had started noticing the "odd twinge now and then" in his right hip.

"The vast majority of days it's fine provided I'm just walking and doing ordinary things. On the odd occasion I might carry something heavy, then I would notice it the next day and it (right hip) would stay painfulintermittentlyfor the next couple of days," Lopert said.

Sean Gallup

In this picture from February, German Chancellor Angela Merkel looks through a microscope at brain organoids grown from stem cells.

Some of his stem cells had been retained after the treatment, and he was booked in for a follow-up injection for his right hip at the end of October.

He expected the therapy would become a "go to" treatment, and would become an early intervention for osteoarthritis. But more independent research was needed to confirm the success of the treatment. "The evidence is slowly building up but there needs to be more before the Government will accept it," Lopert said.

In his case, he thought there had been cartilage regeneration in his hips, but that was based on his symptoms. "It would have been nice had I had MRI scans before and after the injection for objective evidence," he said.

From the perspective of the medical establishment, the New Zealand Orthopaedic Association said it supported a position statement on stem cell therapy produced by the Royal Australian College of Surgeons.

That paper, approved in mid-2018,noted stem cell therapy was a "rapidly advancing" area, but many proposed stem cell therapies were experimental and not yet proven. It did not support surgeons administering stem cell therapy outside of an ethically approved registered clinical trial.

"Whilst there may be scope for innovative treatment in the future, currently, the clinical effectiveness and safety of stem cell therapies remain scientifically unproven," RACS said.

In this country, an ACC spokesperson said ACC did not have an official position on stem cell therapy for the treatment of injuries. An internationally standardised evidence-based healthcare approach was used to help ACC decide how it covered injuries and funded treatments.

Dr HassanMubark, ReGen's chief medical officer, was a healthcare provider contracted to ACC in the specialty of rheumatology, and ACC had funded consultation fees with Mubark, the spokesperson said. Those consultations were for diagnostic and treatment planning purposes and did not need prior approval from ACC.

ACC had to consider legislative criteria when deciding whether to fund any particular treatment. There would be many reasons why ACC might decide to fund a client to see a rheumatologist for an opinion on the diagnosis and possible management of their condition. That would not commit ACC to funding any proposed treatment but would provide the client and ACC with information to help decision-making.

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