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NCT Number: NCT06794294

Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on 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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Seoul, Korea, 07061, South Korea

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

+82-2-870-3246

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Biological

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

Primary outcomes

  1. Shoulder pain and disability index(SPADI) Score

    Time frame: 6 months

    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.

Secondary outcomes

  1. Constant-Murley score

    Time frame: 6 months

    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.

  2. Visual Analog Scale(VAS) pain in motion

    Time frame: 6 months

    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.

  3. Changes in the size of rotator cuff tears determined by MRI

    Time frame: 6 months

  4. Changes in the size of rotator cuff tears determined by arthroscopy

    Time frame: 6 months

  5. Adverse event

    Time frame: 6 months

Other outcomes

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

    Time frame: 6 months

    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.

  2. STR (Short tandem repeat) analysis

    Time frame: 6 months

    STR analysis at post-injection

  3. Visual Analog Scale_pain at night

    Time frame: 6 months

  4. Visual Analog Scale(VAS) worst pain

    Time frame: 6 months

    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.

  5. Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)

    Time frame: 6 months

  6. Muscle strength (lb)

    Time frame: 6 months

    The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale

  7. Pulse rate (beats per minute)

    Time frame: 6 months

    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate

  8. Blood Pressure (mmHg)

    Time frame: 6 months

    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure

  9. CBC(complete blood count)

    Time frame: 6 months

    The measures are composite.

  10. Usage amount of rescue medication

    Time frame: 6 months

    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.

  11. Frequency of rescue medication

    Time frame: 6 months

    The frequency of rescue medication usage is measured to assess how often participants required additional medication to manage symptoms during the study period.

  12. Blood Glucose

    Time frame: 6 months

    Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.

  13. BUN/Creatinine Ratio

    Time frame: 6 months

    The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.

  14. Serum Total Protein

    Time frame: 6 months

    Serum total protein levels are measured to evaluate overall protein status

  15. Serum Albumin

    Time frame: 6 months

    Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.

  16. Serum total bilirubin

    Time frame: 6 months

    Serum total bilirubin levels are measured to evaluate liver function

  17. Aspartate Transaminase/Alanine Transaminase(AST/ALT)

    Time frame: 6 months

    AST and ALT levels are measured to assess liver function

  18. Serum Alkaline Phosphatase(ALP)

    Time frame: 6 months

    Serum ALP levels are measured to evaluate liver and bone health.

  19. Serum Gamma-Glutamyl Transferase(γ-GTP)

    Time frame: 6 months

    Serum γ-GTP levels are measured to assess liver function

  20. Serum creatine kinase(CK)

    Time frame: 6 months

    Serum creatine kinase levels are measured to assess muscle injury

  21. Erythrocyte Sedimentation Rate(ESR)

    Time frame: 6 months

    ESR is measured to assess inflammation or detect inflammatory conditions

  22. C-Reactive Protein(CRP)

    Time frame: 6 months

    Serum CRP levels are measured to evaluate acute inflammation

  23. Urine pH Levels

    Time frame: 6 months

    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.

  24. Urine Specific Gravity

    Time frame: 6 months

    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

  25. Urine Protein

    Time frame: 6 months

    Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or <20 mg/dL.

  26. Urine Glucose

    Time frame: 6 months

    Urine glucose levels are measured to detect glycosuria. Normal range is negative.

  27. Urine Bilirubin

    Time frame: 6 months

    Urine bilirubin levels are measured to assess liver function. Normal range is negative.

  28. Urine Blood

    Time frame: 6 months

    Urine blood levels are measured to detect hematuria. Normal range is negative

  29. Urine Ketone

    Time frame: 6 months

    Urine ketone levels are measured to detect ketonuria. Normal range is negative

  30. Microscopic Analysis

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

KeeJeong Bae, Principal Investigator

CONTACT

[email protected]

+82-10-5202-7469

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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