Overview

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

Eligibility

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