Una comparación de la eficacia clínica de Mytocel MSK con inyecciones de AMT y PRP en pacientes con osteoartritis de rodilla
Osteoarthritis is the most common joint disease, frequently affecting the knee joint. As the cartilage within the joint wears down, the balance between degeneration and regeneration is gradually disrupted, causing pain during joint movement.
Mytocel MSK with AMT (Autologous Micrograft Technology) is an autologous micrograft technology, the first biocompatible solution that can be directly implanted into the joint using the patient's own tissue. It possesses regenerative repair and pain-relieving effects, rapidly improving joint health and alleviating pain and stiffness. It is primarily applied to the musculoskeletal system; this therapy has been proven to have tissue regeneration potential and effectiveness in multiple medical fields. This project will harvest ear cartilage tissue, mechanically separate and precisely filter it to create a Mytocel MSK with AMT cell suspension rich in cartilage precursor cells and mesenchymal stem cell markers (CD44, CD90, CD117), which will then be injected into the knee joint cavity. It is expected to help patients repair cartilage, reduce pain, and improve their quality of life.
PRP is a common treatment for knee osteoarthritis, but its effects are short-lived and require multiple injections. Mytocel MSK with AMT may achieve longer-term and more stable clinical improvement with a single application. This project will use questionnaires and MRI examinations to observe changes in pain, functional recovery, and the degree of cartilage repair before and after treatment. The data will be used to analyze and compare the differences between Mytocel MSK with AMT and PRP treatment.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chung Yuh Tzeng
- Número de teléfono: 886-9921375166
- Correo electrónico: tcy0545@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female participants aged 18 years or older
- Radiographic diagnosis of knee osteoarthritis with Kellgren-Lawrence (KL) grade 1 to 3
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Diagnosis of rheumatoid arthritis
- Advanced knee osteoarthritis requiring total knee arthroplasty
- Diagnosis of autoimmune disease
- Severe meniscal tear or ligament injury requiring surgical intervention
- Body mass index (BMI) greater than 30 kg/m²
- Platelet count less than 100,000 per microliter
- Severe genu varum or genu valgum deformity
- Intra-articular corticosteroid injection within 3 months prior to screening
- Intra-articular hyaluronic acid injection within 6 months prior to screening
- Pregnant or breastfeeding women
- Known human immunodeficiency virus (HIV) infection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mytocel MSK with AMT
PRP is a common treatment for knee osteoarthritis, but its effects are short-lived and require multiple injections. Mytocel MSK with AMT may achieve longer-term and more stable clinical improvement with a single application. This project will use questionnaires and MRI examinations to observe changes in pain, functional recovery, and the degree of cartilage repair before and after treatment. The data will be used to analyze and compare the differences between Mytocel MSK with AMT and PRP treatment. |
PRP is a common treatment for knee osteoarthritis, but its effects are short-lived and require multiple injections. Mytocel MSK with AMT may achieve longer-term and more stable clinical improvement with a single application. This project will use questionnaires and MRI examinations to observe changes in pain, functional recovery, and the degree of cartilage repair before and after treatment. The data will be used to analyze and compare the differences between Mytocel MSK with AMT and PRP treatment. |
|
Experimental: PRP is a common treatment for knee osteoarthritis
PRP is a common treatment for knee osteoarthritis, but its effects are short-lived and require multiple injections. |
PRP is a common treatment for knee osteoarthritis, but its effects are short-lived and require multiple injections. Mytocel MSK with AMT may achieve longer-term and more stable clinical improvement with a single application. This project will use questionnaires and MRI examinations to observe changes in pain, functional recovery, and the degree of cartilage repair before and after treatment. The data will be used to analyze and compare the differences between Mytocel MSK with AMT and PRP treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
Periodo de tiempo: 52 weeks
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated questionnaire assessing pain, stiffness, and physical function in patients with knee osteoarthritis. The total score ranges from 0 to 96, with higher scores indicating worse symptoms. The outcome measure will be the change in total WOMAC score from baseline to 52 weeks. |
52 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in cartilage thickness on magnetic resonance imaging (MRI) at 52 weeks
Periodo de tiempo: 52 weeks
|
Magnetic resonance imaging (MRI) will be performed at baseline and 52 weeks to assess structural changes in knee cartilage. Cartilage thickness will be quantitatively measured and compared between time points. |
52 weeks
|
|
Change from baseline in Visual Analog Scale (VAS) pain score at 52 weeks
Periodo de tiempo: 52 weeks
|
Pain will be assessed using a 10-centimeter Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. The outcome measure will be the change in VAS score from baseline to 52 weeks. |
52 weeks
|
|
Patient Global Impression of Change (PGIC) score at 52 weeks
Periodo de tiempo: 52 weeks
|
The Patient Global Impression of Change (PGIC) is a 7-point scale assessing patients' overall perception of improvement after treatment. Scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater perceived improvement. |
52 weeks
|
|
Change from baseline in 36-Item Short Form Health Survey (SF-36) total score at 52 weeks
Periodo de tiempo: 52 weeks
|
The 36-Item Short Form Health Survey (SF-36) is a validated quality-of-life questionnaire assessing physical and mental health domains. Scores range from 0 to 100, with higher scores indicating better health status. The outcome measure will be the change in total score from baseline to 52 weeks. |
52 weeks
|
|
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 52 weeks
Periodo de tiempo: 52 weeks
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported questionnaire assessing pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this study, KOOS is scored on a scale ranging from 0 to 100, with lower scores indicating better knee function and fewer symptoms. The outcome measure will be the change in total KOOS score from baseline to 52 weeks |
52 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AMT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
There are currently no plans to provide IPD services
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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