An advertorial for The Regenerative Clinic, seen in the national press on 25 February 2020, featured the headline “Ground Breaking Treatment For Arthritis Sufferers … Why struggle with persistent joint pain?”. Text within the body of the article stated “If you suffer from arthritis, or recovering from sports injury, or you’re living with debilitating joint pain as a result of wear and tear, you may well have been told that joint replacement surgery is your only option. Well, think again, as that’s not always the case. Regenerative therapies enable your body to use its own built-in regenerative abilities”. The ad referred to various therapies offered by The Regenerative Clinic, including Activated Messenchymal Pericyte Plasma (AMPP), Platelet Rich Plasma Therapy (RPR) and Lipogems. Further text stated “These non-surgical therapies are extremely successful, and their effectiveness is backed up by extensive clinical research”, and a further article gave the story of a patient and the treatment she received.
IssueThe complainant challenged whether the claims that The Regenerative Clinic’s therapies were effective for joint pain and arthritis were misleading and could be substantiated.
ResponseThe Regenerative Clinic Ltd provided a clinical review on stem cell based treatments for knee osteoarthritis, a literature review on Lipogems and a PowerPoint presentation of their results, which they said they had recently delivered at Middle Eastern healthcare exhibition Arab Health. The Regenerative Clinic referred to three clinical trials on Lipogems and three further supporting clinical publications which they said demonstrated the successful therapeutic use of the treatment. They provided a summary report on adipose-derived stromal cells for osteoarthritis treatment and a National Institute for Health and Care Excellence (NICE) guidance document on platelet-rich plasma injections for knee osteoarthritis.
The ASA noted the headline “Ground Breaking Treatment for Arthritis Sufferers … Why struggle with persistent joint pain?” underneath the bullet-pointed text which stated “Access the world’s most advanced non-surgical techniques at The Regenerative Clinic”, “Choose breakthrough biological treatments as an alternative to joint surgery” and “Get back to your busy lifestyle with minimal recovery time”. Alongside that text were six radiographic images in which a spine, an elbow joint, a wrist joint, a knee joint and a hip were each highlighted in amber, implying they were inflamed. Beneath those images sat text which stated “The Regenerative Clinic offers a range of non-invasive treatments for arthritis, sports injuries and joint problems. These advanced techniques provide patients with life-changing alternatives to surgery”.
Three further headlines outlined the available treatments. A further headline to the right of the images stated “Leading the way in regenerative therapies” The page also included the story of a woman who was given the Lipogems treatment after a near fatal road traffic accident, in which she stated, “Since receiving treatment I have been able to sleep. I have been able to return to playing sport and most importantly I have been able to enjoy family activities and interact with my daughter the way a parent should without the restriction of so much pain”. In that context, we considered that through the combination of the images, claims such as “life-changing” and “These non-surgical therapies are extremely successful, and their effectiveness is backed up by extensive clinical research” and references to sufferers having been able to return to their previous lifestyle, consumers would understand from the ad that The Regenerative Clinic offered three types of new and breakthrough treatment which could provide permanent pain relief to those who suffered from arthritis and persistent joint discomfort. We therefore expected the advertiser to hold evidence to demonstrate that was the case.
We assessed the evidence provided by the advertiser. In respect of the Lipogems treatment, they referred to an ongoing randomised controlled trial of 39 patients with grade three to four osteoarthritis of the knee. We were not provided with a fully copy of the trial, so it was not possible to assess the results. Although the advertiser stated the initial results showed pain reduction and functional improvement in the treatment group after six months, patient recruitment was still ongoing with the trial. As the trial was not yet complete and therefore had not been subject to peer review, we did not consider it sufficient to support the claims made in the ad.
The second article was a double-blind randomised self-controlled trial carried out on 16 patients with grade two to three bi-lateral knee osteoarthritis. As above, we had not been provided with a full copy of the trial, so were unable to analyse the results. And, while it appeared that those who had received the treatment showed a significant improvement after 12 months, we did not consider that this demonstrated permanent pain relief, nor did we consider a trial conducted on 16 patients sufficient to demonstrate the effects of the treatment.
The third article was a double-blinded randomised placebo-controlled trial whereby 12 patients with grade two to three osteoarthritis were provided the treatment. Again, we had not been provided with a full copy of the trial, and we did not consider it sufficient for the same reasons. The Regenerative Clinic then referred to three further publications as supporting evidence. The first was conducted on dogs, the second was a non-randomised (and therefore uncontrolled) trial on 17 patients and the third sought to assess the treatment’s effect on diabetic foot ulcer. Consequently, we did not consider the further evidence sufficient to demonstrate that the Lipogems treatment provided a long-lasting effect on relieving arthritis and joint pain in the various areas of the body referenced in the ad. We then assessed the evidence in respect of Platelet Rich Plasma Therapy (PRP). The NICE guidance provided by the advertiser stated that NICE did a rapid review of the published literature on the efficacy and safety of the procedure.
That review stated that outcome measures of self-reported pain relief and knee function were subjective and could be confounded by various factors, and that while the studies included in the review concluded that intra-articular knee injection of PRP was safe and effective, more high-quality randomised controlled trials were still needed to support efficacy. It also stated that few trials reported favourable outcomes of PRP injections for treatment of knee osteoarthritis in terms of pain relief and self-supported functional improvement in the short-term (at three to 12 months follow-up) compared with other injections, and that long-term clinical effectiveness was unknown. In addition, we did not consider the summary report on adipose-derived stromal cells for osteoarthritis treatment sufficient in demonstrating the effects of Activated Messenchymal Pericyte Plasma (AMPP).
The Executive Summary showed each of the 18 patients was injected with the treatment at varying doses, so no control or placebo group existed. The report itself concluded that a randomised controlled trial was warranted before conclusion on efficacy could be taken. The report also referred to further studies conducted on animals, which we did not consider sufficient to demonstrate the effects on humans. The further documents provided by the advertiser, namely the literature review and the PowerPoint presentation, lacked the methodology and independent statistical analysis of a robust clinical trial or academic review which we expected an advertiser to hold in order to substantiate such claims. While the literature review referred to further trials conducted on Lipogems treatment, we were not provided with those trials so were unable to assess the results. And in any case, the review only monitored treatment outcomes at six months and a year.
Similarly, the PowerPoint presentation referred to clinical publications which we had not been provided with. The treatment outcomes were considered up to two years, which we felt was insufficient to demonstrate the permanent pain relief that was implied by the ad. In light of the above, we concluded that the claims, as consumers were likely to understand them, namely that the treatments listed in the ad were able to provide permanent relief to those who suffered from arthritis and persistent joint pain, had not been substantiated and were therefore misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in the form complained of. We told The Regenerative Clinic Ltd to ensure they did not claim or imply that their treatments permanently relieved pain associated with arthritis and joint problems unless they held robust evidence to substantiate those claims.