Critics of regenerative medicine procedures like PRP injections and stem cell therapy often cite the lack of clinical data proving the procedures help patients suffering from musculoskeletal injuries, osteoarthritis, etc. Proponents counter within endless lists of case studies they believe show the efficacy of regenerative medicine for such applications. This leads to the inevitable question of whether case studies have a place in the discussion.
Medical science has long relied on hard and fast clinical data to determine whether a certain procedure or pharmacological treatment should be offered to patients. This is not a bad strategy at all. In fact, requiring hard and fast clinical data before things are approved by the FDA is one of the ways our system keeps patients safe. The challenge for the regenerative medicine industry lies in the fact that certain kinds of PRP and stem cell therapies do not have to be FDA approved, thus clinical studies are limited.
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Justifying the Need for Case Studies
The Advanced Regenerative Medicine Institute explains that the FDA has already established guidelines for using autologous stem cell and PRP material in an outpatient setting. As long as that material is not processed or altered in ways the FDA does not approve of, it can be used to treat patients without any further approval. Herein lies the reason regenerative medicine proponents rely so heavily on case studies.
Take a PRP procedure for treating osteoarthritis. The material for the treatment is derived from blood drawn from the patient him/herself. That blood is processed in a centrifuge to concentrate the platelets. The resulting material is then injected into the patient to promote healing. That is all there is to it.
Because the material has not been significantly altered or treated in such a way as to require FDA approval, no approval will be sought. And that is not without reason. Why would a doctor or clinic spend millions of dollars and up to a decade of time attempting to get FDA approval for something that doesn’t need to be approved? Just the thought of doing so is absurd.
Clinics are not avoiding clinical studies and FDA approval because their procedures do not really work. It is just a case of not having to by law. There is no point spending the money or time in a prolonged process wrought with red tape and politics.
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Case Studies Are Beneficial
Regenerative medicine critics are fully aware that FDA approval is not required for certain kinds of procedures. And yet, they question the benefits of case studies as a substitute for hard and fast clinical data. That’s a mistake. Case studies have always been a source of supplemental information that often proves helpful in determining the efficacy of a particular treatment.
The fact is that small-scale studies involving fewer than a dozen patients are really just case studies. Furthermore, epidemiology – considered the cornerstone of modern medicine in many circles – relies heavily on the case study method for research and analysis. If case studies are valid for establishing casual links between certain maladies and possible influences, they are equally valid as evidence of the efficacy of regenerative medicine treatments.
Case studies are beneficial in the arena of PRP and stem cell treatments because they tell us what actual patients experience. Without those case studies, we would be left to guess. In the absence of black-and-white clinical data, case studies fill data gaps rather nicely.
Yes, case studies do have a place in the regenerative medicine discussion. To dismiss them is to ignore a viable source of research data.
