NCT06794294RecruitingPhase 1
A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease
Seoul National University Hospital1 site in 1 country21 target enrollmentStarted: January 17, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Shoulder pain and disability index(SPADI) Score
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients diagnosed with partial-thickness rotator cuff tear
Experimental
Intervention: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell (Biological)
Outcomes
Primary Outcomes
Shoulder pain and disability index(SPADI) Score
Time Frame: 6 months
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.
Secondary Outcomes
- Constant-Murley score(6 months)
- Visual Analog Scale(VAS) pain in motion(6 months)
- Changes in the size of rotator cuff tears determined by MRI(6 months)
- Changes in the size of rotator cuff tears determined by arthroscopy(6 months)
- Adverse event(6 months)
Investigators
Study Sites (1)
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