Orthopaedic surgeons have come out strongly against stem-cell interventions being practised, saying they are of unproven benefit, with an unclear scientific basis, and resulting in “uncontrolled and unethical experimentation on patients”.

The nature of these treatments still lacks high-level substantiation, the Association of Orthopaedic and Trauma Surgeons of Malta said in a position paper, claiming “little to no evidence of long-term efficacy, and certainly no lasting long-term structural improvement”.  

For these reasons, AOTSM, said it could not recommend adult stem cell therapy as a validated treatment option for musculoskeletal conditions. 

It called for stakeholders, including patient advocacy groups, medical societies and regulatory agencies, to come together to raise awareness, educate physicians and patients and ascertain the differences between rigorously-tested stem cell interventional therapy against the “unproven nebulousness of what are currently research alternatives”.

Uncontrolled and unethical experimentation on patients

Listing the issues associated with stem cell therapy for orthopaedic conditions, the association mentioned an unknown mechanism of action in most cases, insufficient pre-clinical data, unconfirmed product quality, inadequate information disclosures to patients and no informed consent.

Informed consent meant that patients needed to be aware that most ‘stem cell therapies’, as practised locally, with claims of efficacy and safety, were not founded on clinical evidence, the association explained. 

It pointed out that some proponents for stem cell therapies portrayed exclusively positive messages, without providing a fair balance of the risks, benefits and limitations of the treatment.

The AOTSM warned that patients seeking this form of treatment “have to take due consideration of the risks involved, particularly if they fall in a vulnerable category”.

Osteoarthritis is a common, progressively incapacitating condition, impacting mostly weight-bearing joints of the body.

Pain is a main issue, which also resulted in stiffness, awkwardness in movement, progressive inability to continue with most activities of daily living and a major downturn in the quality of life.  

“It is understandable, therefore, that patients in pain, immobile and stiff, would turn to what looks like the superficially easier option of regenerative therapy,” the orthopaedic surgeons acknowledged.

For the State, osteoarthritis meant a major loss of earnings and an increasingly “skyrocketing” health budget, which will continue to rise exponentially for the future. 

But unlike other debilitating conditions, including rheumatoid arthritis, there was no disease-modifying option for osteoarthritis, and the only way out was, ultimately, a total joint arthroplasty with all the associated costs, complications and extensive rehabilitation, the orthopaedic surgeons explained.

Apart from osteoarthritis, an increasing number of musculoskeletal conditions were being targeted for the stem cell therapy option, they said.

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