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

NCT07374679 | Not Yet Recruiting

• 1 other identifier: ASB-LTFUP-001
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  60months

Secondary Outcomes (4)

• Constant-Murley score

  60 months

• Visual Analog Scale(VAS) pain in motion

  60 months

• Changes in the size of rotator cuff tears determined by MRI

  60 months

• Adverse event

  60 months

Study Arms (1)

Long-term Follow-up Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who previously received the investigational medicinal product in the Phase 1/2a clinical trial (ASB-IP-001) and who voluntarily agreed to participate in this long-term follow-up observational study by providing written informed consent. Participants are followed longitudinally to assess long-term safety and clinical outcomes, without any additional therapeutic intervention.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seoul, Korea, 07061, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

WBC, RBC, Hemoglobin, Hematocrit, Platelet, Differential count (Neutrophil, Lymphocytes, Monocytes, Eosinophils, Basophils) Sodium, Potassium Glucose, BUN, Creatinine, Total protein, Albumin, Total bilirubin, AST, ALT, ALP, γ-GTP, CK, ESR, CRP pH, gravity, protein, glucose, bilirubin, blood, ketone \& microscopic

Central Study Contacts

KeeJeong Bae, Principal Investigator

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): May 30, 2031
• Study Completion (Estimated): January 30, 2032
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)