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1.
Pain Physician ; 23(2): E85-E131, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32214287

RESUMO

BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.


Assuntos
Transplante de Medula Óssea/normas , Medicina Baseada em Evidências/normas , Doenças Musculoesqueléticas/terapia , Manejo da Dor/normas , Médicos/normas , Sociedades Médicas/normas , Medula Óssea/fisiologia , Transplante de Medula Óssea/métodos , Medicina Baseada em Evidências/métodos , Humanos , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Dor/diagnóstico , Dor/epidemiologia , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration/normas
2.
J Shoulder Elbow Surg ; 28(1): 112-119, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30551782

RESUMO

BACKGROUND: Medial epicondylitis and lateral epicondylitis are among the most common elbow pathologies affecting people aged between 40 and 50 years. Although epicondylitis is often a self-limiting condition that improves with conservative treatment, the condition can be difficult to eradicate. The purpose of this study was to compare the effectiveness of platelet-rich plasma (PRP) injections and ultrasound-guided percutaneous tenotomy (Tenex) for the treatment of medial or lateral epicondylitis. Our hypothesis was that the Tenex procedure would not be inferior to PRP injections in the treatment of medial or lateral epicondylitis. METHODS: In this retrospective review, 62 of 75 patients were available for contact via phone and e-mail to complete post-procedure patient-reported outcome surveys. Subjective assessment of pain and function included a visual analog scale for pain; the Quick Disabilities of the Arm, Shoulder and Hand questionnaire; and the EuroQol-5D questionnaire. The inclusion criteria included age of 18 years or older and previous failure of nonoperative treatment. RESULTS: The average ages in the PRP and Tenex groups were 47 years and 51 years, respectively. The PRP cohort (n = 32) included 10 female and 22 male patients, whereas the Tenex cohort (n = 30) included 12 female and 18 male patients. The PRP and Tenex groups both demonstrated clinical and statistical improvement in visual analog scale pain scores; Quick Disabilities of the Arm, Shoulder and Hand scores; and EuroQol-5D scores. No statistically significant difference was found between the 2 treatment modalities. CONCLUSION: The PRP and Tenex procedures were both successful in producing clinically and statistically significant improvements in pain, function, and quality of life.


Assuntos
Plasma Rico em Plaquetas , Cotovelo de Tenista/terapia , Tenotomia , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento , Escala Visual Analógica , Adulto Jovem
3.
Clin J Sport Med ; 27(2): e6-e8, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27177204

RESUMO

Posttraumatic headaches (PTHs) are one of the most frequently reported symptoms after a sport concussion, and treatment options for chronic PTH are limited. In this report, we present a case of a 17-year-old boy with persistent PTH after a sport concussion successfully treated with an intranasal sphenopalatine block.


Assuntos
Concussão Encefálica/complicações , Cefaleia Pós-Traumática/terapia , Bloqueio do Gânglio Esfenopalatino , Adolescente , Traumatismos em Atletas/complicações , Futebol Americano/lesões , Humanos , Masculino , Cefaleia Pós-Traumática/etiologia
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