En sammenligning af den kliniske effekt af Mytocel MSK med AMT- og PRP-injektioner hos patienter med knæartrose
En sammenligning af klinisk effekt af Mytocel MSK med AMT- og PRP-injektioner hos patienter med knæartrose
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Chung Yuh Tzeng
- Telefonnummer: 886-9921375166
- E-mail: tcy0545@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in cartilage thickness on magnetic resonance imaging (MRI) at 52 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- AMT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
There are currently no plans to provide IPD services
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