Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
18 de mayo de 2026 actualizado 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
38
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kyoung Hwan Koh
- Número de teléfono: +82-2-3010-3530
- Correo electrónico: osdoc.koh@gmail.com
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 05505
- Asan Medical Center
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Contacto:
- Sarah Hwang
- Número de teléfono: +82-2-3010-8674
- Correo electrónico: tpfkzlxl@naver.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Comparador de placebos
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Administration of normal saline as a placebo control.
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Experimental: Grupo de dosis alta
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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Experimental: Grupo de Dosis Media
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in the size of rotator cuff tears determined by MRI
Periodo de tiempo: 6months
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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.
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6months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder pain and disability index(SPADI) Score
Periodo de tiempo: 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
Periodo de tiempo: 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.
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6months
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Visual Analog Scale(VAS) pain
Periodo de tiempo: 6months
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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
Periodo de tiempo: 6months
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6months
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Histological Evaluation of Tendon Tissue
Periodo de tiempo: 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.
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6months
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Short tandem repeat (STR) evaluation of tendon tissue
Periodo de tiempo: 6months
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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.
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6months
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Amount and frequency of rescue medication use
Periodo de tiempo: 6months
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6months
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Adverse events
Periodo de tiempo: 6months
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6months
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Height
Periodo de tiempo: 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
Periodo de tiempo: 6months
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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.
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6months
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Systolic and Diastolic blood pressure
Periodo de tiempo: 6months
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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.
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6months
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Pulse rate
Periodo de tiempo: 6months
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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.
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6months
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Complete blood count
Periodo de tiempo: 6months
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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
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Serum chemistry test
Periodo de tiempo: 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
Periodo de tiempo: 6months
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- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination
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6months
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Alloimmune test
Periodo de tiempo: 6months
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
19 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R-3-0023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .