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Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears

2026년 5월 18일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

38

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
    • Seoul
      • Seoul, Seoul, 대한민국, 05505
        • Asan Medical Center
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 비교기
의약품: Normal Saline
Administration of normal saline as a placebo control.
실험적: 고용량군
생물학적: umbilical cord-derived mesenchymal stem cell
Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
실험적: 중간 용량 그룹
생물학적: umbilical cord-derived mesenchymal stem cell
Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in the size of rotator cuff tears determined by MRI
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Shoulder pain and disability index(SPADI) Score
기간: 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.
6months
Constant-Murley score
기간: 6months
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
Visual Analog Scale(VAS) pain
기간: 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.
6months
Location and size of the rotator cuff tear assessed by arthroscopy
기간: 6months
6months
Histological Evaluation of Tendon Tissue
기간: 6months
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
Short tandem repeat (STR) evaluation of tendon tissue
기간: 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
Amount and frequency of rescue medication use
기간: 6months
6months
Adverse events
기간: 6months
6months
Height
기간: Visit 1
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
Visit 1
Weight
기간: 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
Systolic and Diastolic blood pressure
기간: 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
기간: 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
Complete blood count
기간: 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
기간: 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
Urinalysis
기간: 6months
- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination
6months
Alloimmune test
기간: 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.

  • Antigen test: HLA-A, HLA-B, HLA-DR
  • Antibody test: PRA-I, PRA-II

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kyoung Hwan Koh

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R-3-0023

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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