La seguridad/eficacia de la terapia con células madre mesenquimales hUC （19#iSCLife®-OA） para pacientes con osteoartritis
This is a random, abierto, y experimento controlado paralelo. Todos los pacientes son seleccionados y firman formularios de consentimiento., luego dividido en 3 grupos. Los médicos recopilan la información básica del paciente.. All patients receive laboratory and image examination as baseline. Entonces, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 semanas, 1, 2, 3, 6, y 12 months after treatment, and do safety and efficacy evaluation.
Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, velocidad de sedimentación globular, and tumor marker, etc..
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (resonancia magnética) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
