Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
2026年5月18日 更新者：Kyoung Hwan Koh
A Multi-center Study on Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
調査の概要
研究の種類
介入
入学 (推定)
38
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kyoung Hwan Koh
- 電話番号：+82-2-3010-3530
- メール：osdoc.koh@gmail.com
研究場所
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Seoul
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Seoul、Seoul、韓国、05505
- Asan Medical Center
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コンタクト：
- Sarah Hwang
- 電話番号：+82-2-3010-8674
- メール：tpfkzlxl@naver.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged 19 years or older
- Shoulder pain lasting for at least 3 months
- A pain visual analogue scale (VAS) score of 4 or greater
- Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy
- Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI)
- No restrictions on participation in clinical trial procedures, including hospitalization
Exclusion Criteria:
- Receipt of subacromial injection therapy in the affected shoulder within the past 3 months
- History of rotator cuff surgery on the affected shoulder within the past 6 months
- Previous treatment with a stem cell therapy for the shoulder
- Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months
- Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury
- Presence of symptomatic cervical spine disease
- Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- Clinical trial subjects with neurological deficits
- Pregnant or breastfeeding women
- Unwillingness to use an effective method of contraception during participation in the clinical trial
- Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease
- Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness
- Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule
- Participation in another clinical trial within 3 months prior to enrollment in this clinical trial
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボコンパレーター
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Administration of normal saline as a placebo control.
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実験的：高用量群
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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実験的：中用量群
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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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 |
|---|---|---|
|
Changes in the size of rotator cuff tears determined by MRI
時間枠：6months
|
The location, width (AP size), length (ML size), and depth of the rotator cuff tear will be measured on oblique coronal, axial, and sagittal MRI images where the tear is most clearly visualized.
The same measurements will be performed on the corresponding planes after administration of the investigational product and compared with those obtained before administration.
|
6months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Shoulder pain and disability index(SPADI) Score
時間枠：6months
|
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
The minimum value is 0 and the maximum value is 10.
"0" means no pain and "10" means the worst pain imaginable in the pain section.
"0" means no difficulty and "10" means so difficult it requires help in the pain section.
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6months
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Constant-Murley score
時間枠：6months
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The Constant score assesses pain, function, ROM, and strength.
Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points.
The component scores are summated to achieve a maximum possible total score of 100.
|
6months
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Visual Analog Scale(VAS) pain
時間枠：6months
|
Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
A higher score indicates greater pain intensity.
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6months
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Location and size of the rotator cuff tear assessed by arthroscopy
時間枠：6months
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6months
|
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Histological Evaluation of Tendon Tissue
時間枠：6months
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If tendon regeneration at the lesion site is confirmed by arthroscopic examination before and after administration of the investigational product, a tissue sample approximately 2 mm in diameter will be collected from the regenerated area and evaluated using the modified Astrom and Movin scoring system.
|
6months
|
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Short tandem repeat (STR) evaluation of tendon tissue
時間枠：6months
|
STR testing will be performed using a portion of the collected tendon tissue.
The results will be compared with those of the investigational product and the clinical study participant's blood to evaluate the origin of the regenerated tendon tissue.
|
6months
|
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Amount and frequency of rescue medication use
時間枠：6months
|
6months
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Adverse events
時間枠：6months
|
6months
|
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Height
時間枠：Visit 1
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The investigator will perform physical examinations according to the clinical study schedule, based on medical judgment.
Height will be measured only at Visit 1. Height will be measured in centimeters
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Visit 1
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Weight
時間枠：6months
|
The investigator will perform physical examinations at each visit according to the clinical study schedule, based on medical judgment.
Body weight will be measured in kilograms at each visit.
|
6months
|
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Systolic and Diastolic blood pressure
時間枠：6months
|
The investigator will check systolic and diastolic blood pressure at each visit according to the clinical study schedule, based on medical judgment.systolic
and diastolic blood pressure will be measured in a seated position.
|
6months
|
|
Pulse rate
時間枠：6months
|
The investigator will check pulse rate at each visit according to the clinical study schedule, based on medical judgment.
Pulse rate will be measured in a seated position.
|
6months
|
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Complete blood count
時間枠：6months
|
Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water. - WBC, RBC, hemoglobin, hematocrit, platelets, and differential count |
6months
|
|
Serum chemistry test
時間枠：6months
|
- general: glucose, BUN/creatinine, total protein, albumin, total bilirubin, AST/ALT, ALP, γ-GTP, CK, ESR, CRP Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water. |
6months
|
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Urinalysis
時間枠：6months
|
- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination
|
6months
|
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Alloimmune test
時間枠：6months
|
Clinical study participants will visit the study site at Visit 2 (treatment) and Visit 3 (exploratory efficacy and safety assessment) to undergo alloimmune testing.
If a positive response is observed in the PRA test, the following additional tests will be performed: - HLA Single Ag I, HLA Single Ag II |
6months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年4月19日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月26日
QC基準を満たした最後の更新が送信されました
2026年5月18日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R-3-0023
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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