Background: Regenerative cell therapies, such as adipose-derived stromal vascular fraction (SVF), have been postulated as potential treatments for knee osteoarthritis (KOA). Objectives: To assess the efficacy and safety of SVF treatment against placebo and other standard therapies for treating KOA in adult patients. Design: A systematic review. Data sources and methods: We searched the following databases: MEDLINE via PubMed, Epistemonikos, PEDro, DynaMed, TripDatabase, Elsevier via Clinicalkey and Cochrane Controlled Trials Register. We included prospective interventional studies where treatment with SVF in adults with KOA was compared against placebo or other standard therapies, and results were objectively measured with at least one widely recognised osteoarthritis scale. Results: Among 266 studies published until May 2021, nine met our inclusion criteria. A total of 239 patients (274 knees) were included in our study. The follow-up ranged from 6 to 24 months. Six studies had a control group (only one being placebo). All studies showed that SVF improved pain and functionality measured, in most cases, with the visual analogue scale and the Western Ontario and McMaster Universities Osteoarthritis Index. In addition, five studies reported an improvement in anatomical structures, as detected in MR images. However, the number of cells contained in SVF varied substantially between different studies, which could induce a comparison bias. Conclusion: Although based on a small number of dissimilar studies, SVF was considered a safe treatment for KOA and could be promising in terms of pain, functionality and anatomical structure improvement. However, SVF products need to be standardised, the number of cells homogenised and the use of concomitant treatments reduced to establish proper comparisons. Registration: PROSPERO registration number: CRD42021284187.
Resumen El sistema sanitario se encuentra ante una pandemia mundial en relación con la enfermedad por coronavirus 2019. Los planes de preparación para emergencias a menudo no consideran cuestiones específicas de rehabilitación para pacientes hospitalizados ni para ambulatorios, aunque la Organización Mundial de la Salud aconseja incluir a profesionales de rehabilitación lo antes posible. Los planes de contingencia de los servicios de rehabilitación deben realizarse en coordinación con las otras áreas asistenciales. En esta revisión se ha resumido y analizado la información disponible sobre la enfermedad por coronavirus 2019 basada en una búsqueda cuidadosa de la literatura científica y en la experiencia de un entorno concreto, para planificar la continuidad asistencial de rehabilitación para todos los pacientes y para ayudar a los equipos de rehabilitación en este periodo de confinamiento/desconfinamiento incierto.
Background There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise. Objective This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders. Methods This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models. Results The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020. Conclusions The Postural garment is expected to improve cervical pain by enhancing posture. Trial Registration ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492 International Registered Report Identifier (IRRID) DERR1-10.2196/14807
Biologic therapies have huge potential in orthopaedic sports medicine. 4 To reach scientific evidence on stem cells or platelet-rich plasma, many articles of the American Journal of Sports Medicine have addressed this issue. The article by Yokota and coworkers 6 has provided new insight into the role of mesenchymal stem cells (MSCs) on osteoarthritis treatment. It is worth pointing out that Japan's Regenerative Medicine Promoting Act on the Safety of Regenerative Medicine makes it easier to develop research in this field. However, heterogeneity among formulations is the more relevant drawback to obtain definite conclusions when comparing results of different studies. The understanding of the mechanism of action is hampered, among others, by this lack of international standards. 1,5 In their study ''Comparative Clinical Outcomes After Intra-articular Injection With Adipose-Derived Cultured Stem Cells or Noncultured Stromal Vascular Fraction for the Treatment of Knee Osteoarthritis,'' Yokota et al did not specify the stromal vascular fraction (SVF) product composition before the injection. The authors stated that ''the number of cells injected was unknown for the SVF group as the entire 5 mL of SVF produced was subsequently injected.'' We believe that this is a methodological pitfall that could lead to inconsistent conclusions. The authors established that ''adipose stem cells (ASCs) are as safe as and potentially more effective than SVF for intra-articular injection in patients with knee osteoarthritis.'' Obviously, comparison between these 2 cohorts is not feasible, since the number of SVF-viable cells is unknown. Furthermore, the authors concluded that the ASC treatment outperformed the SVF one partly because of the lower proportion of hematopoietic cells and higher frequency of colony-forming unit fibroblasts. There is consistent scientific evidence that MSCs' beneficial effect is achieved through an immunomodulatory and paracrine mechanism. 2 Concerning this, SVF has better cell composition to permit MSC action. Another point to comment is the administration of nonsteroidal anti-inflammatory drugs after the injection. There is scientific evidence to suggest a potential interaction between these drugs and a regenerative medicine product; thus, their use is not recommended immediately after the biological treatment injection. 3 For all of the aforementioned, we firmly believe that the study's weaknesses undermine its conclusions.
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