Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease

Seoul National University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Rotator Cuff Disease

Treatments

Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Study type

Interventional

Funder types

Other

Identifiers

NCT06794294

ASB-IP-001

Details and patient eligibility

About

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

Enrollment

21 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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