Rotator Cuff Disease
Conditions
Brief summary
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
Interventions
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 1x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 19 years of age and older. * Patients with unilateral shoulder pain lasting for at least 3months * Patients who do not respond to conservative treatment. * Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months * Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US). * Patients without any restrictions on clinical trial procedures, including hospitalization.
Exclusion criteria
* Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months. * Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months * Patients with a history of receiving stem cell therapy for the shoulder. * Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy. * Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space. * Patients presenting with symptomatic cervical spine disorders. * Patients with concurrent bilateral shoulder pain * Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia. * Patients with neurological deficit * Pregnant women or lactating mothers. * Patients unwilling to use effective contraception during the clinical trial period. * Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test. * Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies. * Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication. * Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules. * Patients who have participated in another clinical trial within the last 3 months. * Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain and disability index(SPADI) Score | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley score | 6 months | 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. |
| Visual Analog Scale(VAS) pain in motion | 6 months | 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. |
| Changes in the size of rotator cuff tears determined by MRI | 6 months | — |
| Changes in the size of rotator cuff tears determined by arthroscopy | 6 months | — |
| Adverse event | 6 months | — |
Countries
South Korea
Contacts
CONTACTKeeJeong Bae, Principal Investigator
Outcome results
None listed