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NCT Number: NCT06817616

Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears

Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears

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Key information

Conditions

Rotator Cuff Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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
  • Unilateral shoulder pain with a pain score of 4 or higher.
  • patients with a symptom duration of at least three months who have not responded to conventional treatments, including analgesics.
  • patients diagnosed with massive or extensive full-thickness rotator cuff tears confirmed by computed tomography arthrography or magnetic resonance imaging.

Exclusion criteria

  • patients diagnosed with small or medium full-thickness rotator cuff tears among study participants with full-thickness rotator cuff tears.
  • patients who have received subacromial injection therapy in the affected shoulder within the past three months.
  • patients who have undergone rotator cuff surgery on the affected shoulder within the past six months.
  • patients exhibiting or suspected of having the following radiological findings: malignant tumors, severe glenohumeral osteoarthritis, or bony abnormalities causing subacromial space narrowing.
  • patients presenting with symptomatic cervical spine disorders.
  • patients experiencing bilateral shoulder pain.
  • patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
  • patients with neurological deficits.
  • Pregnant or breastfeeding patients
  • patients unwilling to use effective contraception during the study period.
  • patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result.
  • patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies.
  • patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders.
  • Any other cases deemed inappropriate for study participation by the investigator.

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: 2.5X10 cells/0.5mL
  • 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: 5X10 cells/1mL
  • Number of injections: Only once during the study period
  • Device: Ultrasound
  • Injection technique: Injection into the lesion by investigator

Primary outcomes

  1. Visual Analog Scale(VAS) pain in motion

    Time frame: 12 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.

Secondary outcomes

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

    Time frame: 12 months

  2. Adverse event

    Time frame: 12 months

Other outcomes

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

    Time frame: 12 months

  2. Muscle strength (lb)

    Time frame: 12 months

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

  3. Pulse rate (beats per minute)

    Time frame: 12 months

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

  4. Blood Pressure (mmHg)

    Time frame: 12 months

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

  5. CBC(complete blood count)

    Time frame: 12 months

    The measures are composite.

  6. Usage amount of rescue medication

    Time frame: 12 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.

  7. Frequency of rescue medication

    Time frame: 12 months

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

  8. Blood Glucose

    Time frame: 12 months

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

  9. BUN/Creatinine Ratio

    Time frame: 12 months

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

  10. Serum Total Protein

    Time frame: 12 months

    Serum total protein levels are measured to evaluate overall protein status

  11. Serum Albumin

    Time frame: 12 months

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

  12. Serum total bilirubin

    Time frame: 12 months

    Serum total bilirubin levels are measured to evaluate liver function

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

    Time frame: 12 months

    AST and ALT levels are measured to assess liver function

  14. Serum Alkaline Phosphatase(ALP)

    Time frame: 12 months

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

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

    Time frame: 12 months

    Serum γ-GTP levels are measured to assess liver function

  16. Serum creatine kinase(CK)

    Time frame: 12 months

    Serum creatine kinase levels are measured to assess muscle injury

  17. Erythrocyte Sedimentation Rate(ESR)

    Time frame: 12 months

    ESR is measured to assess inflammation or detect inflammatory conditions

  18. C-Reactive Protein(CRP)

    Time frame: 12 months

    Serum CRP levels are measured to evaluate acute inflammation

  19. Urine pH Levels

    Time frame: 12 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.

  20. Urine Specific Gravity

    Time frame: 12 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

  21. Urine Protein

    Time frame: 12 months

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

  22. Urine Glucose

    Time frame: 12 months

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

  23. Urine Bilirubin

    Time frame: 12 months

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

  24. Urine Blood

    Time frame: 12 months

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

  25. Urine Ketone

    Time frame: 12 months

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

  26. Microscopic Analysis

    Time frame: 12 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.

  27. Number of participants with treatment-related adverse events as assessed by NCI - CTCAE v4.0

    Time frame: 12 months

    all adverse and unintended signs (including abnormal laboratory test results), symptoms, or diseases that occur in research subjects who have been administered the investigational drug.

Study contacts

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

Woong Kyo Jeong

CONTACT

[email protected]

82-10-4047-2878

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 18, 2025

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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