A Comparison of Clinical Efficacy of Mytocel MSK With AMT and PRP Injections in Patients With Knee Osteoarthritis

Обзор

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.

Вмешательства

• Биопрепарат PRP
  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 treatme

Первичные конечные точки

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07453953 · AMT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗