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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.
PM R ; 11(10): 1093-1100, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-30688030

RESUMO

BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent and increases the risk of osteoporosis, falls, and fractures. Patients in acute inpatient rehabilitation have several risk factors for VDD, the adverse effects of which may hinder long-term functional gain. OBJECTIVE: To evaluate the prevalence of and risk factors for VDD in patients admitted to acute inpatient rehabilitation and to evaluate the efficacy of a standardized vitamin D screening and supplementation protocol. DESIGN: Prospective cohort study as part of a quality improvement initiative. SETTING: An academic, freestanding acute inpatient rehabilitation hospital. PARTICIPANTS: Patients consecutively admitted over a 4-month period between November 2014 and February 2015 (n=128 pre-intervention and n=129 post-intervention). INTERVENTION: Universal screening of vitamin D level on admission followed by utilization of a standard supplementation protocol. MAIN OUTCOME MEASURES: Vitamin D insufficiency (VDI) and VDD prevalence along with screening, and supplementation rates. RESULTS: Preintervention, 10.2% of patients were screened for VDD, with 23.1% VDI and 46.2% VDD. Postintervention, 89.9% were screened, with 31.9% VDI and 47.4% VDD. 6.3% of all patients were supplemented on vitamin D preintervention compared to 53.5% postintervention. In multivariate analyses, the odds of VDD was significantly associated with African American race (OR 7.30, 95% CI, 1.56-34.20, P = .12) and age younger than 65 (OR 13.62 95% CI, 2.51-73.83, P = .002). Diagnoses in the "other neurologic" category were associated with decreased odds of VDD (OR 0.01, 95% CI, 0.001-0.193, P = .002). CONCLUSIONS: Given the high prevalence of VDD in an acute inpatient rehabilitation hospital, a routine screening and standardized supplementation protocol may improve quality of care. LEVEL OF EVIDENCE: III.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Melhoria de Qualidade , Deficiência de Vitamina D/prevenção & controle , Vitamina D/administração & dosagem , Acidentes por Quedas/prevenção & controle , Afro-Americanos , Fatores Etários , Estudos de Coortes , Feminino , Fraturas Espontâneas/prevenção & controle , Hospitais de Reabilitação , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Osteoporose/prevenção & controle , Amostragem , Sudeste dos Estados Unidos , Vitamina D/sangue
3.
Regen Med ; 14(12): 1151-1154, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31960759

RESUMO

Aim: To describe the successful treatment of coccydynia using ultrasound-guided injection of platelet-rich plasma. Setting: Outpatient orthopedic practice. Patient: 17-year-old female with BMI of 42.6. Case description: The patient presented with 6 months of nontraumatic coccygeal pain exacerbated by sitting. Physical exam was significant for point-tenderness over the sacral hiatus and coccyx. A corticosteroid injection around the sacrococcygeal ligament was administered with immediate resolution of her pain following the injection with the anesthetic. The patient reported significant pain relief for 1 week. The superficial sacrococcygeal ligament was then treated with a platelet-rich plasma injection under US guidance. Results: The patient reported a 70% improvement in pain and sitting tolerance at 6 weeks. By 6 months post injection, her pain was 100% resolved, and she remained pain free at the 12-month follow-up. Conclusion: Platelet-rich plasma may be considered as a treatment option in patients with refractory coccydynia.


Assuntos
Cóccix/fisiopatologia , Dor/prevenção & controle , Plasma Rico em Plaquetas/citologia , Medicina Regenerativa , Adolescente , Feminino , Humanos
4.
Cleft Palate Craniofac J ; 54(6): 720-725, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-27243667

RESUMO

OBJECTIVE: To compare anthropometric z-scores with incidence of post-operative complications for patients undergoing primary cleft lip or palate repair. DESIGN: This was a retrospective observational analysis of patients from a surgical center in Assam, India, and includes a cohort from a single surgical mission completed before the opening of the center. SETTING: Patients included in the study underwent surgery during an Operation Smile mission before the opening of Operation Smile's Guwahati Comprehensive Cleft Care Center in Guwahati, India. The remaining cohort received treatment at the center. All patients received preoperative assessment and screening; surgery; and postoperative care, education, and follow-up. PATIENTS, PARTICIPANTS: Our sample size included 1941 patients and consisted of all patients with complete information in the database who returned for follow-up after receiving primary cleft lip repair or primary cleft palate repair between January 2011 and April 2013. INTERVENTIONS: Preoperative anthropometric measurements. MAIN OUTCOME MEASURE(S): Postoperative complications. RESULTS: Anthropometric z-scores were not a significant predictor of adverse surgical outcomes in the group analyzed. Palate surgery had increased risk of complication versus lip repair, with an overall odds ratio of 5.66 (P < .001) for all patients aged 3 to 228 months. CONCLUSIONS: Anthropometric z-scores were not correlated with increased risk of surgical complications, possibly because patients were well screened for malnutrition before surgery at this center. Primary palate repair is associated with an approximate fivefold increased risk of developing postoperative complication(s) compared with primary lip repair.


Assuntos
Antropometria/métodos , Fenda Labial/cirurgia , Fissura Palatina/cirurgia , Complicações Pós-Operatórias/epidemiologia , Medição de Risco/métodos , Adolescente , Criança , Pré-Escolar , Fenda Labial/epidemiologia , Fissura Palatina/epidemiologia , Feminino , Humanos , Incidência , Índia/epidemiologia , Lactente , Masculino , Missões Médicas , Cuidados Pré-Operatórios , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
5.
Breast ; 24(5): 618-22, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26199197

RESUMO

PURPOSE: Margin status is important in guiding decisions to re-excise following breast-conserving surgery (BCS) for breast cancer. The College of American Pathologists (CAP) developed guidelines to standardize pathology reporting; however, compliance with margin documentation guidelines has been shown to vary. The aim of this retrospective study was to determine whether compliance with CAP guidelines affects re-excision and mastectomy rates. METHODS: We identified 1423 patients diagnosed with breast cancer between 1998 and 2006 who underwent BCS with negative margins. CAP compliance was categorized as maximal, minimal, or non-compliant. Statistical analyses were performed comparing the frequency of re-excision and mastectomy after initial BCS according to CAP margin reporting guideline compliance. Data were adjusted for provider facility by including a clustering variable within the regression model. RESULTS: Patients with non-compliant margin reporting were 1.7 times more likely to undergo re-excision and/or mastectomy than those with maximally compliant reporting. Level of compliance was most strongly associated with the frequency of mastectomy; non-compliant margin reporting was associated with a 2.5-fold increase in mastectomy rates compared to maximally compliant reporting. The results did not substantially change when the analyses accounted for clustering at the provider facility level. CONCLUSIONS: Our findings suggest that compliance with CAP guidelines in pathology reporting may be associated with variation in re-excision and mastectomy rates following BCS.


Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Carcinoma Intraductal não Infiltrante/cirurgia , Documentação/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Mastectomia Segmentar , Adulto , Idoso , Carcinoma Intraductal não Infiltrante/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasia Residual , Patologia/normas , Guias de Prática Clínica como Assunto , Reoperação/estatística & dados numéricos
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