膝関節症患者におけるMytocel MSKとAMTおよびPRP注射の臨床的有効性の比較
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.
調査の概要
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：Chung Yuh Tzeng
- 電話番号：886-9921375166
- メール：tcy0545@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 52 weeks
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cartilage thickness on magnetic resonance imaging (MRI) at 52 weeks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- AMT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
There are currently no plans to provide IPD services
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。