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

NCT06794294 | Recruiting Phase 1

• 1 other identifier: ASB-IP-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

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.

  6 months

Secondary Outcomes (5)

• 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

Other Outcomes (30)

• Change in degeneration score compared to baseline and the rate of change through histological examination

  6 months

• STR (Short tandem repeat) analysis

  6 months

• Visual Analog Scale_pain at night

  6 months

Study Arms (1)

Patients diagnosed with partial-thickness rotator cuff tear

EXPERIMENTAL

Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Interventions

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell BIOLOGICAL

Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 1x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator

Patients diagnosed with partial-thickness rotator cuff tear

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

RECRUITING

Central Study Contacts

KeeJeong Bae, Principal Investigator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 27, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

KR (1)