Long-Term Follow-up Study to Evaluate Long-Term Safety and Efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients With Rotator Cuff Disease

Seoul National University Hospital21 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rotator Cuff Disease

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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).

Locations (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, Korea, South Korea

RECRUITING

Outcomes

Primary Outcomes

Shoulder pain and disability index(SPADI) Score

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.

Time frame: 60months

Secondary Outcomes

Constant-Murley score

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.

Time frame: 60 months

Visual Analog Scale(VAS) pain in motion

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.

Time frame: 60 months

Changes in the size of rotator cuff tears determined by MRI

Time frame: 60 months

Number of Participants with Adverse event

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.

Central Contacts

KeeJeong Bae, Principal Investigator

CONTACT

+82-10-5202-7469 grant903@gmail.com

Data from ClinicalTrials.gov

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