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

NCT ID: NCT06794294

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with partial-thickness rotator cuff tear

Group Type: EXPERIMENTAL

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Intervention Type: 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

Interventions

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, Korea, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

KeeJeong Bae, Principal Investigator

Role: CONTACT

grant903@gmail.com

+82-10-5202-7469

Facility Contacts

Clinical Research Coordinator

Role: primary

eunmiahn@scorlab.kr

+82-2-870-3246

Other Identifiers

ASB-IP-001

Identifier Type: -

Identifier Source: org_study_id