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Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial

  • Authors:
    • Ivan Delgado‑Enciso
    • Jose Valtierra‑Alvarez
    • Juan Paz‑Garcia
    • Jorge Preciado‑Ramirez
    • Alejandro D. Soriano‑Hernandez
    • Martha A. Mendoza‑Hernandez
    • Jose Guzman‑Esquivel
    • Ariana Cabrera‑Licona
    • Josuel Delgado‑Enciso
    • Jose L. Cortes‑Bazan
    • Iram P. Rodriguez‑Sanchez
    • Margarita L. Martinez‑Fierro
    • Ana O. Cabrera‑Medina
    • Carlos E. Barajas‑Saucedo
    • Brenda Paz‑Michel
  • View Affiliations / Copyright

    Affiliations: Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28000, Mexico, Department of Traumatology, University Regional Hospital, Colima State Health Services, Colima 28019, Mexico, Department of Traumatology, Union Hospital Center, Villa de Alvarez, Colima 28970, Mexico, Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico, Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico, Department of Research, Foundation for Cancer Ethics, Education and Research of The Cancerology State Institute, Colima 28085, Mexico, Department of Cellular Biology, School of Biological Sciences, Autonomous University of Nuevo Leon, Monterrey, Nuevo Leon 64460, Mexico, Molecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas 98160, Mexico, Department of Research, Esteripharma Mexico, Mexico City 03100, Mexico
    Copyright: © Delgado‑Enciso et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Pages: 3351-3360
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    Published online on: March 13, 2019
       https://doi.org/10.3892/etm.2019.7384
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Abstract

Osteoarthritis (OA) is a major public health problem characterized by joint pain, fatigue, functional limitation and decreased quality of life of the patient, which results in increased use of healthcare services and high economical costs. A promising novel bioactive cell‑free formulation (BIOF2) for cartilage regeneration has recently been tested in pre‑clinical and clinical trials, and has demonstrated a success rate similar to that of total joint arthroplasty for the treatment of severe knee OA. The present study evaluated the efficacy of treatment with BIOF2, by including it within a conservative regimen of ‘usual medical care’ of knee OA, and whether its efficacy was affected in subgroups of patients presenting with comorbidities that exacerbate OA. A prospective, randomized, 2‑arm parallel group phase III clinical trial was conducted, which included 105 patients in the ‘usual medical care’ group (paracetamol/NSAIDs and general care provided by the family physician) and 107 patients in the BIOF2 group (usual medical care + intra‑articular BIOF2 application at 0, 1 and 2 months). Two aspects were evaluated at 0, 6 and 12 months: i) Minimal clinically important improvement (MCII), based on 30% improvement of pain from the baseline; and ii) the Patient Acceptable Symptom State (PASS), a questionnaire that determines patient well‑being thresholds for articular pain and function. Adverse effects and regular NSAID use were registered. At 12 months, BIOF‑2 treatment produced MCII in 70% of the patients and >50% achieved PASS. Excluding the patients with class 2 obesity or malalignment conditions (genu varum or genu valgum >20 degrees), the experimental treatment produced MCII and PASS in 100 and 92% of patients, respectively, compared with 25 and 8% in the group of usual medical care (P<0.001). No patient with malalignment and treatment with BIOF2 achieved PASS. Notably, there were no serious adverse effects. To conclude, BIOF2 is a safe therapeutic alternative that is easy to implement together with usual medical care for knee OA. Trial registration: Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000277. Retrospectively registered June, 2018.
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Copy and paste a formatted citation
Spandidos Publications style
Delgado‑Enciso I, Valtierra‑Alvarez J, Paz‑Garcia J, Preciado‑Ramirez J, Soriano‑Hernandez AD, Mendoza‑Hernandez MA, Guzman‑Esquivel J, Cabrera‑Licona A, Delgado‑Enciso J, Cortes‑Bazan JL, Cortes‑Bazan JL, et al: Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial. Exp Ther Med 17: 3351-3360, 2019.
APA
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A.D., Mendoza‑Hernandez, M.A. ... Paz‑Michel, B. (2019). Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial. Experimental and Therapeutic Medicine, 17, 3351-3360. https://doi.org/10.3892/etm.2019.7384
MLA
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A. D., Mendoza‑Hernandez, M. A., Guzman‑Esquivel, J., Cabrera‑Licona, A., Delgado‑Enciso, J., Cortes‑Bazan, J. L., Rodriguez‑Sanchez, I. P., Martinez‑Fierro, M. L., Cabrera‑Medina, A. O., Barajas‑Saucedo, C. E., Paz‑Michel, B."Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial". Experimental and Therapeutic Medicine 17.5 (2019): 3351-3360.
Chicago
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A. D., Mendoza‑Hernandez, M. A., Guzman‑Esquivel, J., Cabrera‑Licona, A., Delgado‑Enciso, J., Cortes‑Bazan, J. L., Rodriguez‑Sanchez, I. P., Martinez‑Fierro, M. L., Cabrera‑Medina, A. O., Barajas‑Saucedo, C. E., Paz‑Michel, B."Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial". Experimental and Therapeutic Medicine 17, no. 5 (2019): 3351-3360. https://doi.org/10.3892/etm.2019.7384
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Spandidos Publications style
Delgado‑Enciso I, Valtierra‑Alvarez J, Paz‑Garcia J, Preciado‑Ramirez J, Soriano‑Hernandez AD, Mendoza‑Hernandez MA, Guzman‑Esquivel J, Cabrera‑Licona A, Delgado‑Enciso J, Cortes‑Bazan JL, Cortes‑Bazan JL, et al: Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial. Exp Ther Med 17: 3351-3360, 2019.
APA
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A.D., Mendoza‑Hernandez, M.A. ... Paz‑Michel, B. (2019). Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial. Experimental and Therapeutic Medicine, 17, 3351-3360. https://doi.org/10.3892/etm.2019.7384
MLA
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A. D., Mendoza‑Hernandez, M. A., Guzman‑Esquivel, J., Cabrera‑Licona, A., Delgado‑Enciso, J., Cortes‑Bazan, J. L., Rodriguez‑Sanchez, I. P., Martinez‑Fierro, M. L., Cabrera‑Medina, A. O., Barajas‑Saucedo, C. E., Paz‑Michel, B."Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial". Experimental and Therapeutic Medicine 17.5 (2019): 3351-3360.
Chicago
Delgado‑Enciso, I., Valtierra‑Alvarez, J., Paz‑Garcia, J., Preciado‑Ramirez, J., Soriano‑Hernandez, A. D., Mendoza‑Hernandez, M. A., Guzman‑Esquivel, J., Cabrera‑Licona, A., Delgado‑Enciso, J., Cortes‑Bazan, J. L., Rodriguez‑Sanchez, I. P., Martinez‑Fierro, M. L., Cabrera‑Medina, A. O., Barajas‑Saucedo, C. E., Paz‑Michel, B."Patient‑reported health outcomes for severe knee osteoarthritis after conservative treatment with an intra‑articular cell‑free formulation for articular cartilage regeneration combined with usual medical care vs. usual medical care alone: A randomized controlled trial". Experimental and Therapeutic Medicine 17, no. 5 (2019): 3351-3360. https://doi.org/10.3892/etm.2019.7384
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