試験ID jRCT2033230587
最終情報更新日：2026年10月23日
変形性膝関節症患者を対象としたCLS2901Cの有効性及び安全性を評価する第Ⅲ相試験
基本情報
| 試験ID | jRCT2033230587 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 変形性膝関節症患者を対象としたCLS2901Cの有効性及び安全性を評価する第Ⅲ相試験 | A Phase III Study Evaluating the Efficacy and Safety of CLS2901C in Patients with Osteoarthritis of the Knee |
| 平易な研究名称 / Public Title（Acronym） | A Phase III Study of CLS2901C in Patients with Osteoarthritis of the Knee | |
| 試験進捗状況/Recruitment status | Recruiting | |
| 登録日時 | 2024年1月23日 | |
| 最終情報更新日 | 2026年10月23日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | |
|---|---|---|
| 実施都道府県 | 埼玉県 | |
| 目標症例数/Target sample size | 96 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 変形性膝関節症 | Osteoarthritis of the Knee |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入2 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入3 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入4 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入5 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入6 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入7 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入8 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入9 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 介入10 | 損傷面積の3倍の面積となるシート数を移植（上限15枚）する。 | |
| 主要評価項目 / Primary outcomes | KOOS4のベースラインから術後52週時の変化量 | Absolute change from baseline KOOS4 score at postoperative Week 52 |
| 副次評価項目 / Secondary outcomes | 有効性評価項目 1. KOOS5及び各KOOSサブスコアにおける術前からの変化量 2. Lysholm Knee Score 3. 下肢単純X線写真（KLグレード、%MA（% mechanical axis） 4. 関節鏡検査（ICRS分類、術後（移植後）は任意の検査） 5. MOCART2.0のスコア 6. ［任意］病理検査（OARSI組織学的スコア、Mankinスコア、ICRSⅡ overall assessmentスコア、遺伝子発現解析） 安全性評価項目 有害事象及び不具合発生割合 | Efficacy Endpoints 1. Absolute change from preoperative KOOS5 score and each KOOS subscore 2. Lysholm Knee Score (LKS) 3. Lower extremity X-ray (Kallegren-Lawrence [K-L] grade, percentage of mechanical axis [%MA]) 4. Arthroscopy (International Cartilage Repair Society [ICRS] classification; test is optional after the surgery for this clinical trial) 5. Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 (MOCART 2.0) score 6. Optional: Pathology (Osteoarthritis Research Society International [OARSI] histopathology score, Mankin score, ICRS II overall assessment score, gene expression analysis) Safety Endpoint Incidence proportion of adverse events (AEs) and defects |
適格性
| 年齢（下限）/ Age minimum | 20歳以上 | >= 20age old |
|---|---|---|
| 年齢（上限）/ Age maximum | 80歳未満 | < 80age old |
| 性別 / Gender | 男女両方 | Both |
| 選択基準 / Include criteria | 1) Male or female aged 20 to 79 years at informed consent. 2) Diagnosis of OAK classified as Kellgren-Lawrence (K-L) Grade 2 to 4 based on plain lower extremity X-ray. 3) OAK eligible for proximal tibial osteotomy based on the following criteria: Range of motion (ROM): >=120 degree flexion, <=5 degree extension 4) Preoperative cartilage defect of the femoral condyle/trochlear groove or medial tibial condyle with an area of >=4 cm2 per defect site. 5) Total defect area of <=21 cm2 in individuals with multiple cartilage defects. 6) Body mass index (BMI) <30. 7) No coexisting ligament injury requiring surgery, and no meniscal injury requiring suturing or surgical repair other than partial resection, in the target knee. 8) No history of ligament reconstruction, meniscal suturing, total meniscectomy or bone marrow stimulation, and no history of treatment with regenerative medicine products (including investigational products), cell processing products (including PRP) or gene therapy, in the target knee. 9) No history of treatment with hyaluronic acid products and/or opioid for severe pain in the target knee within 1 month prior to informed consent. 10) No history of treatment with corticosteroid products and/or immunosuppressive drug in the target knee within 3 months prior to informed consent. 11) No history of platelet-rich plasma (PRP) therapy within 6 months prior to informed consent. 12) Non-smoker; provided, however, that smokers will be eligible for study entry if they consent to abstain from smoking from 3 months prior to proximal tibial osteotomy or proximal tibial osteotomy+RMSC until postoperative bone healing. 13) Written informed consent to participate in the study on a voluntary basis. 14) No history of treatment with radiofrequency ablation of peripheral nerves in the knee joint within 1 year prior to informed consent. 15) No history of proximal tibial osteotomy in the non-target knee. 16) No history of treatment using mesenchymal stem cells, mesenchymal stromal cells, or stem cell culture supernatant. | |
| 除外基準 / Exclude criteria | 1) Requires surgical treatment of the non-target knee during the study period. 2) Any coexisting illness that would interfere with surgery under general anesthesia or that would affect knee surgery. 3) Systemic inflammatory disease such as rheumatoid arthritis. 4) Systemic active infectious disease such as bacterial, fungal or viral infection. 5) Serious disease such as liver disorder, renal disorder, heart disease, lung disease, blood disease or metabolic disease that would make the patient unsuitable for study entry in the opinion of the investigator. 6) Diagnosed or suspected malignant tumor or history of malignant tumor within the past 5 years. 7) Uncontrolled psychiatric disorder. 8) Poorly-controlled diabetes (HbA1c: >7.0%). 9) Previous history of septic arthritis of the target knee. 10) Women who are pregnant or breastfeeding, or women of childbearing potential. Women of childbearing potential must agree to use the following contraceptive methods (i.e., contraceptives and medical devices that are approved/certified in Japan) or to abstain completely from sexual intercourse from the time of informed consent and for the study duration (excluding the follow-up period) in order to be eligible for study entry. (a) Primary contraceptive methods: Oral contraceptives, intrauterine devices (IUDs) including progesterone-releasing systems. (b) Adjunctive contraceptive methods: Condoms Use of a primary contraceptive method is mandatory, whereas use of the adjunctive contraceptive method must be in conjunction with a primary contraceptive method. Given that oral contraceptive doses can be missed and that their effects may be diminished when used concomitantly with other medications or dietary health supplements, subjects should consider changing their primary contraceptive method. 11) Received treatment as part of another clinical study within the past 6 months, currently participating in another clinical study, or planning to participate in another clinical study while also participating in the present study. 12) Known history of hypersensitivity to antibiotics (benzylpenicillin potassium, streptomycin sulfate, amphotericin B). 13) Known history of hypersensitivity to bovine-derived materials. 14) Any other reason the investigator deems the subject unsuitable for study entry. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Chikako Sato | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | CellSeed Inc. | |
| 住所 / Address | Telecom Center-Bldg. East, 15F, 2-5-10, Aomi, Koto-ku, Tokyo 135-0064 JAPAN Tokyo Japan 135-0064 | |
| 電話 / Telephone | +81-3-6380-7490 | |
| 実施責任組織 / Affiliation | 佐藤 千香子 | CellSeed Inc. |
| 研究費提供組織 / Funding Source | ||
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | Telecom Center-Bldg. East, 15F, 2-5-10, Aomi, Koto-ku, Tokyo 135-0064 JAPAN Tokyo Japan 135-0064 | |
|---|---|---|
| 電話 / Telephone | +81-3-6380-7490 | |
| ホームページURL | ||
| cs.clinicaldevelopment@cellseed.com | ||
| 担当者 / Name of contact person | Cell Sheet Clinical Development Department CellSeed Inc. |
倫理審査委員会
| 認定臨床研究審査委員会又は倫理審査委員会の名称 | ||
|---|---|---|
| 上記委員会の認定番号 | 住所 / Address | |
| 電話番号 | ||
| 審査受付番号 | ||
| 当該臨床研究に対する審査結果 | ||
| 認定臨床研究審査委員会の承認日 | ||
変更・中止の場合
| 中止届出日 | ||
|---|---|---|
| 中止年月日 | ||
| 中止の理由 | ||
終了の場合
| 終了届出日 | ||
|---|---|---|
| 観察期間終了日 | ||
| 実施症例数 | ||
| 参加者の流れ（Participant flow） | ||
| 研究対象者の背景情報 | ||
| 疾病等の発生状況のまとめ | ||
| 主要評価項目及び副次評価項目のデータ解析及び結果 | ||
| 公開予定日 | ||
| 要約 | ||
| 研究実施計画書のURL | ||
| 結果に関する最初の出版物での発表日 | ||
| 結果と出版物に関するURL | ||
IPD data sharing
| 個々の研究対象者単位のデータ（IPD）を共有する計画 | ||
|---|---|---|
| 計画の説明 | ||