A Comparison of Clinical Efficacy of Mytocel MSK With AMT and PRP Injections in Patients With Knee Osteoarthritis
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: PRP (Biological)
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.
Intervention: PRP (Biological)
Outcomes
Primary Outcomes
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chung Yuh Tzeng
Attending Physician
Taichung Veterans General Hospital