Commentary

Be committed to stem cell therapy

The promise of stem cell therapy is attractive. Through relatively simple and minimally invasive methods, physicians can harvest pluripotent cells from patients, place the cells in the damaged or degenerative area and presumably the cells will modify and stimulate a healing response that regenerates tissue that looks and behaves like normal tissue. The cells can be harvested without compromising the donor area, separated from the non-stem cell environment and rapidly concentrated with special readily available machines, delivering a potentially powerful catalyst to fix abnormal tissue. Most stem cell treatments involve a patient’s own cells. Therefore, the risk of disease transmission, rejection or allergic reaction can be greater minimized.

Unfortunately, the allure of stem cell treatment in an industry-favorable regulatory environment has spawned a multibillion-dollar sector of health care that threatens to erode public trust in our stewardship of musculoskeletal care. The number of properly designed, randomized, controlled trials investigating outcomes of stem cell treatment for orthopedic conditions that include efforts to minimize the placebo effect and other confounding variables is almost non-existent. Many orthopedic centers have not put the effort into designing and leading these studies in a multicenter method due to the lack of funding and of clear evidence of translational treatments from the laboratory to the patient.

Anthony A. Romeo

Most funding for stem cell treatment studies in orthopedics has been industry-based or private. The inconvenient truth is industry and most stem cell providers do not want to risk disrupting current publicopinion on the potential impact of stem cell treatments with scientifically rigorous studies that may not support many claims publicly pronounced and promoted. Claims of proprietary data, nontransparent data acquisition and interpretation, and the lack of oversight by regulatory organizations have allowed many claims on the treatment of musculoskeletal conditions with stem cells to go unchecked.

The Lancet Commission on Stem Cells and Regenerative Medicine concluded: “The combination of poor quality science, unclear funding models, unrealistic hopes, and unscrupulous private clinics threatens regenerative medicine’s social license to operate.” The commission urged rethinking the social contract that supports research and clinical practice and recommends following a strategy of better science, better funding models, better governance, and better public and patient engagement.

Private practice clinics and their direct-to-consumer marketing efforts, combined with growing demand from patients for nonsurgical options, has finally awakened concerns among orthopedic surgeons and researchers who have dedicated their careers to developing trustworthy relationships with scientific peers and patients. We are increasingly asked by patients to consider unproven treatments for common conditions, such as knee arthritis. Due to the inconclusive science behind stem cell treatments, no insurance company pays for stem cell treatment of osteoarthritis. Incredibly, the average cost for stem cell treatment of an arthritic joint is well-above the Medicare reimbursement for knee arthroplasty, and patients are fully responsible for the charges.

Based on an analysis of the NIH Clinical Trials Data Bank, better data and science are on the horizon. Currently, 282 clinical trials have been identified, with one-third of the studies completed. Of the completed studies, one-third have an associated publication for a total of 13% peer-reviewed representation so far. More information obtained with better scientific rigor will help separate fact from fiction and aid communication among patients and peers.

Stem cell therapy holds tremendous promise as part of the “ingredients” for regenerative therapies to treat musculoskeletal conditions. Stem cell treatments for blood-based diseases and cancers have been miraculous. We one day may be able to use stem cells, most likely in combination with extracellular matrices and additional growth factors, to modify and cure some orthopedic conditions. However, those treatments are years away from completed clinical trials.

We must be committed to the science and investigation of stem cell therapies, understand the impact of marketing unproven and potentially harmful treatments and have anintelligent and open dialogue with patients.

Stem cell therapy and other biological interventions have become an accepted part of musculoskeletal care. We must be better stewards of this area to maintain and grow relationships with patients who trust us to consider all appropriate options to achieve the best orthopedic outcomes.

Disclosure: Romeo reports he receives royalties, is on the speakers bureau, is a consultant and does contracted research for Arthrex; receives institutional grants from MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Wright Medical.

The promise of stem cell therapy is attractive. Through relatively simple and minimally invasive methods, physicians can harvest pluripotent cells from patients, place the cells in the damaged or degenerative area and presumably the cells will modify and stimulate a healing response that regenerates tissue that looks and behaves like normal tissue. The cells can be harvested without compromising the donor area, separated from the non-stem cell environment and rapidly concentrated with special readily available machines, delivering a potentially powerful catalyst to fix abnormal tissue. Most stem cell treatments involve a patient’s own cells. Therefore, the risk of disease transmission, rejection or allergic reaction can be greater minimized.

Unfortunately, the allure of stem cell treatment in an industry-favorable regulatory environment has spawned a multibillion-dollar sector of health care that threatens to erode public trust in our stewardship of musculoskeletal care. The number of properly designed, randomized, controlled trials investigating outcomes of stem cell treatment for orthopedic conditions that include efforts to minimize the placebo effect and other confounding variables is almost non-existent. Many orthopedic centers have not put the effort into designing and leading these studies in a multicenter method due to the lack of funding and of clear evidence of translational treatments from the laboratory to the patient.

Anthony A. Romeo

Most funding for stem cell treatment studies in orthopedics has been industry-based or private. The inconvenient truth is industry and most stem cell providers do not want to risk disrupting current publicopinion on the potential impact of stem cell treatments with scientifically rigorous studies that may not support many claims publicly pronounced and promoted. Claims of proprietary data, nontransparent data acquisition and interpretation, and the lack of oversight by regulatory organizations have allowed many claims on the treatment of musculoskeletal conditions with stem cells to go unchecked.

The Lancet Commission on Stem Cells and Regenerative Medicine concluded: “The combination of poor quality science, unclear funding models, unrealistic hopes, and unscrupulous private clinics threatens regenerative medicine’s social license to operate.” The commission urged rethinking the social contract that supports research and clinical practice and recommends following a strategy of better science, better funding models, better governance, and better public and patient engagement.

Private practice clinics and their direct-to-consumer marketing efforts, combined with growing demand from patients for nonsurgical options, has finally awakened concerns among orthopedic surgeons and researchers who have dedicated their careers to developing trustworthy relationships with scientific peers and patients. We are increasingly asked by patients to consider unproven treatments for common conditions, such as knee arthritis. Due to the inconclusive science behind stem cell treatments, no insurance company pays for stem cell treatment of osteoarthritis. Incredibly, the average cost for stem cell treatment of an arthritic joint is well-above the Medicare reimbursement for knee arthroplasty, and patients are fully responsible for the charges.

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Based on an analysis of the NIH Clinical Trials Data Bank, better data and science are on the horizon. Currently, 282 clinical trials have been identified, with one-third of the studies completed. Of the completed studies, one-third have an associated publication for a total of 13% peer-reviewed representation so far. More information obtained with better scientific rigor will help separate fact from fiction and aid communication among patients and peers.

Stem cell therapy holds tremendous promise as part of the “ingredients” for regenerative therapies to treat musculoskeletal conditions. Stem cell treatments for blood-based diseases and cancers have been miraculous. We one day may be able to use stem cells, most likely in combination with extracellular matrices and additional growth factors, to modify and cure some orthopedic conditions. However, those treatments are years away from completed clinical trials.

We must be committed to the science and investigation of stem cell therapies, understand the impact of marketing unproven and potentially harmful treatments and have anintelligent and open dialogue with patients.

Stem cell therapy and other biological interventions have become an accepted part of musculoskeletal care. We must be better stewards of this area to maintain and grow relationships with patients who trust us to consider all appropriate options to achieve the best orthopedic outcomes.

Disclosure: Romeo reports he receives royalties, is on the speakers bureau, is a consultant and does contracted research for Arthrex; receives institutional grants from MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Wright Medical.