Overview

Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears

Eligibility

Inclusion Criteria:

• Male or female 19 years of age and older
• Unilateral shoulder pain with a pain score of 4 or higher.
• patients with a symptom duration of at least three months who have not responded to conventional treatments, including analgesics.
• patients diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by computed tomography arthrography or magnetic resonance imaging.

Exclusion Criteria:

• patients diagnosed with small or medium full-thickness rotator cuff tears among study participants with full-thickness rotator cuff tears.
• patients who have received subacromial injection therapy in the affected shoulder within the past three months.
• patients who have undergone rotator cuff surgery on the affected shoulder within the past six months.
• patients exhibiting or suspected of having the following radiological findings: malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing.
• patients presenting with symptomatic cervical spine disorders.
• patients experiencing bilateral shoulder pain.
• patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
• patients with neurological deficits.
• Pregnant or breastfeeding patients
• patients unwilling to use effective contraception during the study period.
• patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result.
• patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies.
• patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders.
• Any other cases deemed inappropriate for study participation by the investigator.