Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears

Korea University

Status

Enrolling

Conditions

Rotator Cuff Disease

Treatments

Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Study type

Interventional

Funder types

Other

Identifiers

NCT06817616

KUAH-25-01

Details and patient eligibility

About

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

Enrollment

15 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.