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

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woong Kyo Jeong; Phone Number: 82-10-4047-2878; Email: drshoulder@korea.ac.kr

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 02841
      • Recruiting
      • Korea University Anamh Hospital
      • Contact: 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
• 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.

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 Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in the size of rotator cuff tears determined by MRI	12 months
Adverse event	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)		12 months
Muscle strength (lb)	The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale	12 months
Pulse rate (beats per minute)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate	12 months
Blood Pressure (mmHg)	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure	12 months
CBC(complete blood count)	The measures are composite.	12 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.	12 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.	12 months
Blood Glucose	Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.	12 months
BUN/Creatinine Ratio	The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.	12 months
Serum Total Protein	Serum total protein levels are measured to evaluate overall protein status	12 months
Serum Albumin	Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.	12 months
Serum total bilirubin	Serum total bilirubin levels are measured to evaluate liver function	12 months
Aspartate Transaminase/Alanine Transaminase(AST/ALT)	AST and ALT levels are measured to assess liver function	12 months
Serum Alkaline Phosphatase(ALP)	Serum ALP levels are measured to evaluate liver and bone health.	12 months
Serum Gamma-Glutamyl Transferase(γ-GTP)	Serum γ-GTP levels are measured to assess liver function	12 months
Serum creatine kinase(CK)	Serum creatine kinase levels are measured to assess muscle injury	12 months
Erythrocyte Sedimentation Rate(ESR)	ESR is measured to assess inflammation or detect inflammatory conditions	12 months
C-Reactive Protein(CRP)	Serum CRP levels are measured to evaluate acute inflammation	12 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.	12 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	12 months
Urine Protein	Urine protein levels are measured to assess the presence of proteinuria. Normal range is typically negative or <20 mg/dL.	12 months
Urine Glucose	Urine glucose levels are measured to detect glycosuria. Normal range is negative.	12 months
Urine Bilirubin	Urine bilirubin levels are measured to assess liver function. Normal range is negative.	12 months
Urine Blood	Urine blood levels are measured to detect hematuria. Normal range is negative	12 months
Urine Ketone	Urine ketone levels are measured to detect ketonuria. Normal range is negative	12 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.	12 months
Number of participants with treatment-related adverse events as assessed by NCI - CTCAE v4.0	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.	12 months

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KUAH-25-01

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