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

A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease

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

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Disease
• Intervention / Treatment: Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: KeeJeong Bae, Principal Investigator; Phone Number: +82-10-5202-7469; Email: grant903@gmail.com

Study Locations

• South Korea
  • Korea
    • Seoul, Korea, South Korea, 07061
      • Recruiting
      • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
      • Contact: Clinical Research Coordinator; Phone Number: +82-2-870-3246; Email: eunmiahn@scorlab.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients diagnosed with partial-thickness rotator cuff tear

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in degeneration score compared to baseline and the rate of change through histological examination	When tendon regeneration is identified in the lesion area through arthroscopic examination, a tissue sample approximately 2 mm in diameter is collected from the regenerated site and evaluated using the modified Astrom & Movin scoring system. The evaluation method consists of seven assessment variables(Fiber structure, Fiber arrangement, Rounding of the nuclei, Variations in cellularity, Increased vascularity, Decreased stainability, Hyalinization), each scored on a scale from 0 to 3, with 0 indicating normal and 3 representing the most severe abnormality. The scores are summed to calculate the tendon degeneration score, which ranges from 0 to 21. A score closer to 0 indicates normal tendon condition, while a score closer to 21 reflects severe degenerative changes.	6 months
STR (Short tandem repeat) analysis	STR analysis at post-injection	6 months
Visual Analog Scale_pain at night		6 months
Visual Analog Scale(VAS) worst pain	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.	6 months
Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)		6 months
Muscle strength (lb)	The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale	6 months
Pulse rate (beats per minute)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate	6 months
Blood Pressure (mmHg)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure	6 months
CBC(complete blood count)	The measures are composite.	6 months
Usage amount of rescue medication	The total dosage of rescue medication administered to participants during the study period is measured to evaluate the amount of medication required to manage symptoms after treatment.	6 months
Frequency of rescue medication	The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period.	6 months
Blood Glucose	Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.	6 months
BUN/Creatinine Ratio	The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.	6 months
Serum Total Protein	Serum total protein levels are measured to evaluate overall protein status	6 months
Serum Albumin	Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.	6 months
Serum total bilirubin	Serum total bilirubin levels are measured to evaluate liver function	6 months
Aspartate Transaminase/Alanine Transaminase(AST/ALT)	AST and ALT levels are measured to assess liver function	6 months
Serum Alkaline Phosphatase(ALP)	Serum ALP levels are measured to evaluate liver and bone health.	6 months
Serum Gamma-Glutamyl Transferase(γ-GTP)	Serum γ-GTP levels are measured to assess liver function	6 months
Serum creatine kinase(CK)	Serum creatine kinase levels are measured to assess muscle injury	6 months
Erythrocyte Sedimentation Rate(ESR)	ESR is measured to assess inflammation or detect inflammatory conditions	6 months
C-Reactive Protein(CRP)	Serum CRP levels are measured to evaluate acute inflammation	6 months
Urine pH Levels	Urine pH is measured to assess acidity or alkalinity of the urine. Lower values indicate increased acidity, while higher values indicate increased alkalinity. Normal range is typically 4.5-8.0.	6 months
Urine Specific Gravity	Urine specific gravity is measured to evaluate urine concentration or dilution. A value closer to 1.000 indicates more diluted urine, while higher values suggest more concentrated urine. protein	6 months
Urine Protein	Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or <20 mg/dL.	6 months
Urine Glucose	Urine glucose levels are measured to detect glycosuria. Normal range is negative.	6 months
Urine Bilirubin	Urine bilirubin levels are measured to assess liver function. Normal range is negative.	6 months
Urine Blood	Urine blood levels are measured to detect hematuria. Normal range is negative	6 months
Urine Ketone	Urine ketone levels are measured to detect ketonuria. Normal range is negative	6 months
Microscopic Analysis	Microscopic analysis of urine is performed to identify the presence of red blood cells (RBCs), white blood cells (WBCs), crystals, casts, or bacteria, which may indicate infection, inflammation, or other pathological conditions.	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ASB-IP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No