Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
18 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
38
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kyoung Hwan Koh
- Número de telefone: +82-2-3010-3530
- E-mail: osdoc.koh@gmail.com
Locais de estudo
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Seoul
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Seoul, Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Contato:
- Sarah Hwang
- Número de telefone: +82-2-3010-8674
- E-mail: tpfkzlxl@naver.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Comparador de Placebo
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Administration of normal saline as a placebo control.
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Experimental: Grupo de alta dose
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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Experimental: Grupo de Dose Média
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in the size of rotator cuff tears determined by MRI
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Shoulder pain and disability index(SPADI) Score
Prazo: 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
Prazo: 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.
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6months
|
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Visual Analog Scale(VAS) pain
Prazo: 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
|
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Location and size of the rotator cuff tear assessed by arthroscopy
Prazo: 6months
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6months
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Histological Evaluation of Tendon Tissue
Prazo: 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
|
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Short tandem repeat (STR) evaluation of tendon tissue
Prazo: 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
Prazo: 6months
|
6months
|
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Adverse events
Prazo: 6months
|
6months
|
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Height
Prazo: 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
Prazo: 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
Prazo: 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
|
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Pulse rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6months
|
- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination
|
6months
|
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Alloimmune test
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de maio de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R-3-0023
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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