Rotator Cuff Disease
Conditions
Brief summary
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
Interventions
Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
DRUGNormal Saline
Administration of normal saline as a placebo control.
Sponsors
Kyoung Hwan Koh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the size of rotator cuff tears determined by MRI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain and disability index(SPADI) Score | 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. |
| Constant-Murley score | 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. |
| Visual Analog Scale(VAS) pain | 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. |
| Location and size of the rotator cuff tear assessed by arthroscopy | 6months | — |
| Histological Evaluation of Tendon Tissue | 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. |
| Short tandem repeat (STR) evaluation of tendon tissue | 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. |
| Amount and frequency of rescue medication use | 6months | — |
| Adverse events | 6months | — |
| Height | 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 |
| Weight | 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. |
| Systolic and Diastolic blood pressure | 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. |
| Pulse rate | 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. |
| Complete blood count | 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 |
| Serum chemistry test | 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. |
| Urinalysis | 6months | \- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination |
| Alloimmune test | 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 |
Countries
South Korea
Contacts
CONTACTKyoung Hwan Koh
Outcome results
None listed