Porównanie skuteczności klinicznej preparatu Mytocel MSK z iniekcjami AMT i PRP u pacjentów z chorobą zwyrodnieniową stawu kolanowego
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.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Faza
- Wczesna faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Chung Yuh Tzeng
- Numer telefonu: 886-9921375166
- E-mail: tcy0545@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in cartilage thickness on magnetic resonance imaging (MRI) at 52 weeks
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- AMT
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
There are currently no plans to provide IPD services
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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