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NCT Number: NCT07453953

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

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.

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Key information

Conditions

Mytocel MSK With AMT

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Biological

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.

Other outcomes

Change in cartilage thickness on magnetic resonance imaging (MRI) at 52 weeks

Time frame: 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.
Change from baseline in Visual Analog Scale (VAS) pain score at 52 weeks

Time frame: 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.
Patient Global Impression of Change (PGIC) score at 52 weeks

Time frame: 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.
Change from baseline in 36-Item Short Form Health Survey (SF-36) total score at 52 weeks

Time frame: 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.
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 52 weeks

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chung Yuh Tzeng

CONTACT

[email protected]

886-9921375166

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2030
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.