Why are patients STILL at risk from stem cell jabs?
It’s the trendy treatment pushed by UK clinics as the solution to everything from arthritis to autism. But two years after Good Health raised questions about safety and regulation...
APATIENT left blinded in one eye, another who suffered a life-threatening artery blockage and a third now blighted with crippling joint damage — and, claim medics, all three cases reported over the past year have occurred as a result of costly, unproven stem cell treatment at private clinics in the UK.
Yet, astoundingly, this treatment is legal. The UK authorities say the injections don’t count as ‘medical’ procedures, so do not need to be regulated. But many experts take a different view. it is well known that stem cells, which are found in many tissues in the body, particularly bone marrow, hold great medical potential. They are ‘precursor’ cells that can turn into different types of tissue and blood cells. it is hoped that, in the future, they will provide a cure for conditions such as diabetes and cancer.
But not yet. And scientists experimenting with stem cells in accredited UK medical research institutions are governed by strict safety guidelines from the Human Tissue Authority, because the use of stem cells is not without risk. When injected as ‘therapies’, they may, for example, run out of control and transform into rogue — even cancerous — cells.
This danger was first discovered during early attempts at stem cell therapy which involved injecting them into the brains of people with Parkinson’s disease.
Medical stem cell surgery treatments are approved in the UK for only a very few conditions, including some blood cancers, skin grafts and repair of injured corneas. The NHS is also starting to use stem cells as a therapy for multiple sclerosis (MS).
This cautious approach, however, is not always matched by UK private clinics, which are offering stem cell injections for a variety of conditions that range from orthopaedic (arthritic knees) to cosmetic (bags under the eyes) — and often cost thousands of pounds. Yet there is little, if any, evidence that stem cells help with these conditions. This is being allowed to happen because these treatments are not regulated — even though experts warn that they can cripple and, some believe, even kill. Fares Haddad, professor of orthopaedic and sports surgery at University College Hospital in London, told Good Health that he has treated patients harmed by stem cell injections administered by private clinics in the UK.
‘i have seen two patients who had developed blood clots in their thighs as a result of private stem cell surgery that was supposed to repair damaged knee and hip joints,’ says Professor Haddad.
One of them developed a pulmonary embolism, where the blood clot migrated from the thigh to block a vessel in their lung — a medical emergency.
Another patient had severe arthritis that meant she needed a hip replacement.
‘instead,’ says Professor Haddad, ‘she paid to have a clinic put fat-containing stem cells into her hip. She’d been given the false promise that the procedure would regenerate the tissues there.’
in these private operations, stem cells are harvested from the patient’s own fat or bone marrow in the hope that they will perform ‘repair work’ when re-sited (by injection) into the problem area.
‘instead, the patient developed a hip infection after the procedure,’ says Professor Haddad. ‘This made the hip replacement she really needed much harder to do and with a less sure outcome.
‘All these patients’ problems were caused by UK stem cell clinics that falsely promised to repair joint damage with stem cell “regenerative material”,’ he explains. ‘Often these procedures are unnecessary anyway, as well as clinically worthless as they won’t actually help. The problem is spreading like wildfire in the UK.’
There are up to 70 clinics in the UK selling stem cell procedures, according to eric Anthony, director of policy at the international Society for Stem Cell Research based in illinois, in the U.S.
They are allowed to operate as a result of a legal loophole. Professor Haddad explains: ‘All the procedures use “autologous” stem cell transplants, which involve taking fat cells out of a patient’s own body or bone marrow and re-implanting them somewhere else in their body.’
Because the stem cells are injected back
into the same person, unaltered, the process falls outside usual EU legal control and — under the UK authorities’ interpretation — any regulation here.
By contrast, if someone else’s stem cells are injected into a patient, they are defined as an ‘advanced therapy medicinal product’ (ATMP) and are subject to the most rigorous control by expert committees that rule on the ethics and potential curative value of any proposed intervention.
The logic is that with stem cells from a donor there may be risks of rejection by the patient’s body or of them causing infection. But that does not necessarily mean that autologous implants are themselves safe.
Nevertheless, because autologous stem cell transplants can be legally offered here, any reasonable person might assume them to be free from danger.
However, Professor Haddad is convinced they are dangerous, not only because they play with risky stem cell technology but also as the interventions themselves carry risks — and often offer no potential benefit.
Over the past few months, leading medical journals have carried similar warnings about the procedures. Last month in the Annals of Neurology, for example, a survey of more than 200 U.S. neurologists found that one in four had seen tumours, nerve damage, infections, seizures and at least four deaths as a result of patients receiving private stem cell injections from unregulated clinics.
The study was led by Dr Jaime Imitola, an associate professor of neurology, genetics and genome sciences at the University of Connecticut, who warns: ‘The grotesque side-effects from unproven stem cell therapies are more common than we realised.’
Dr Imitola told Good Health that the complications were caused by a variety of problems. ‘we had reports of complications caused by the cells that were injected. Other complications resulted from the way patients were treated — with injection sites becoming infected, for example.’
His reports included a patient with MS who had been treated at an unregulated stem cell clinic and later developed blood cancer, which killed him.
The neurologist who reported this was convinced the stem cells were linked to the cancer.
‘It’s an unethical industry,’ says Dr Imitola. ‘They use fancy websites promising cures which are nothing of the sort.’
TWO years ago, when clinics offering autologous stem cell operations for cosmetic surgery were beginning to appear in the UK, I wrote in these pages warning of the risks and lack of regulation.
None of the relevant regulatory agencies — the Medicines and Healthcare products Regulatory Authority (MHRA), the Care Quality Commission (CQC) and the Human Tissue Authority (HTA) — would initially agree that the clinics came under their remit.
The HTA stepped forward to investigate the four London clinics I had reported to them.
Only one of them still advertises stem cell therapies — the London FAMI Clinic, which offers ‘facial rejuvenation’ injections that ‘use your own stem cells to restore youthful volume and contours’.
It promises: ‘As stem cells keep reproducing, the results can last indefinitely.’
The HTA’s stakeholder engagement manager, Maria-Paulina Socarras, tells me that the authority had given the four London clinics a clean legal bill of health. ‘we concluded that the establishments in question were not carrying out activities at that time that required licensing by the HTA,’ she says. Ms Socarras points out that private UK stem cell clinics are exempt from regulation if they use a patient’s own cells ‘as part of a single surgical procedure’.
But if those very same cells are put into storage prior to use, ‘a HTA licence would be required,’ she adds. Using a fridge might make all the difference, it seems. The approach of other UK regulatory authorities seems just as perplexing. Take, for example, the case reported last year by the CQC of a woman patient who was blinded in one eye by an errant injection of cells into her jaw joint [possibly due to damage to a nerve], at The Regenerative Clinic in London.
The inspection report says the clinic failed to notify the CQC of the incident in a timely fashion, as per regulations. However, the CQC accepted this was an ‘oversight’.
The report added that the clinic’s records showed ‘the incident had been managed effectively — and the service had altered its technique in relation to the specific procedure to avoid repetition’.
The CQC told Good Health it has no role in evaluating the clinical worth of the operation.
The clinic’s chief executive, Simon Checkley, told the BBC earlier this year that they ‘take every complication very seriously,’ adding: ‘Now, we’ve only had one complication in 1,700 cases.’
Meanwhile, other clinics continue to offer expensive stem cell therapies for conditions where there is no reputable clinical evidence to show they can help.
The Autism Regenerative Centre in London is offering stem cell treatments for autism for children over the age of two. Bone marrow cells are taken from the child under general anaesthetic and reinjected into a vein or their spinal canal, according to its website.
It claims stem cells are beneficial for autism because they can ‘restore damaged cells and tissues regulating memory, concentration, attention and speech in the brain’. Up to three treatments, each costing £9,500, may be prescribed.
DARIUS widera, associate professor of stem cell biology and regenerative medicine at Reading University, says: ‘Autism cannot be treated with stem cells,’ he states plainly. ‘These cells are unable to generate into any cell types apart from fat, bone cells or cartilage.’
In April, a committee of the EU’s medical product watchdog, the European Medicines Agency (EMA), warned the public against ‘using unregulated cell-based therapies which may not be safe or effective — for conditions such as cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss’.
It said that ‘these treatments can pose serious risks to patients for little or no benefit’.
Nevertheless, clinics offering such therapies continue to proliferate, thanks not least to celebrity endorsement from the likes of rock star Ozzy Osbourne who, it was said in April, had been helped with his Parkinson’s disease symptoms.
Princess Michael of Kent, too, appeared in a promotional video for a clinic in the Bahamas that offers stem cell therapy for problem joints such as her painful shoulder.
‘Look at that,’ the Princess declared, holding her right arm high above her head. ‘It’s amazing — I think stem cells are the future, there’s no doubt in my mind.’
Such celebrity endorsements can easily overshadow warnings from medical experts.
The solution, says Professor Haddad, is straightforward. The UK’s health regulators must rigorously control autologous stem cell transplants by classing them as medical interventions — which is precisely what they are, he says.
A spokesman for the MHRA says: ‘Regarding the regulation of procedures involving autologous stem cells in private clinics in the UK, we are currently consulting with relevant stakeholders and reviewing their submissions.’
Two years after Good Health’s initial investigation into these stem cell injections, the toll of damage continues to mount. How many more people must fall victim before UK regulators finally act?