Rotator Cuff Disease
Conditions
Brief summary
The purpose of this study is to evaluate Long-Term Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who received the investigational medicinal product in the Phase 1/2a clinical trial (ASB-IP-001). * Subjects who voluntarily agreed to participate in this long-term follow-up study and provided written informed consent.
Exclusion criteria
* Subjects who cannot be contacted by any means, including telephone, mail, or e-mail, and for whom follow-up assessment is therefore not feasible. * Subjects deemed inappropriate for participation in this long-term follow-up study at the investigator's discretion, including: * Cases in which participation in the study may pose a significant risk to the subject's health or safety; ② Cases in which long-term follow-up visits or assessments are practically impossible due to cognitive impairment, communication difficulties, or similar conditions; ③ Cases in which continued participation in follow-up is unlikely due to difficulty adhering to the study schedule (e.g., prolonged hospitalization, long-term residence abroad).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain and disability index(SPADI) Score | 60months | 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
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley score | 60 months | The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100. |
| Visual Analog Scale(VAS) pain in motion | 60 months | Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
| Changes in the size of rotator cuff tears determined by MRI | 60 months | — |
| Number of Participants with Adverse event | 60 months | Adverse events will be collected from Visit 2 to Visit 6. The following information will be collected: adverse event term, start date/end date, adverse event category, severity of the adverse event, causal relationship with the investigational product, seriousness of the adverse event, and final outcome. |
Countries
South Korea
Contacts
CONTACTKeeJeong Bae, Principal Investigator
Outcome results
None listed