Christopher J Centeno1, Hasan Al-Sayegh2, Michael D Freeman3,4, Jay Smith5, William D Murrell6, Rostyslav Bubnov7. 1. Centeno-Schultz Clinic, Regenerative Sciences, LLC, 403 Summit Blvd, Broomfield, CO, 80021, USA. Centenooffice@centenoschultz.com. 2. Biostatistician at Boston Children's Hospital, 450 Brookline Avenue, D-155E, Boston, MA, 02215, USA. 3. Department of Psychiatry, Oregon Health and Science University School of Medicine, Portland, OR, USA. 4. CAPHRI School of Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands. 5. Mayo Clinic Rochester, 200 1st St SW, Rochester, MN, 55905, USA. 6. American Musculoskeletal Wellness Institute, P.C, 6701 Democracy Boulevard Suite 300, Bethesda, Maryland, 20817, USA. 7. The Centre of Ultrasound Diagnostics and Interventional Sonography, Clinical Hospital "Pheophania" of State Affairs Department, Zabolotny Street, 21, 03680, Kyiv, Ukraine.
Abstract
INTRODUCTION: The purpose of the present investigation is to report on detailed complications among a much larger group of 2372 orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years. METHODS: All patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software. RESULTS: A total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain post-procedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone. CONCLUSION: Lowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.
INTRODUCTION: The purpose of the present investigation is to report on detailed complications among a much larger group of 2372 orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years. METHODS: All patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software. RESULTS: A total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain post-procedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone. CONCLUSION: Lowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.
Entities:
Keywords:
Bone marrow concentrate; Complications; Mesenchymal stem cells; Platelet rich plasma; Registry; Side effects
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