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

February 17, 2025 updated by: Woong Kyo Jeong, Korea University Anam Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

  1. Injection dosage and volume of the study drugs:

    • Low dose: 2.5X10 cells/0.5mL
  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: 5X10 cells/1mL

  2. Number of injections: Only once during the study period
  3. Device: Ultrasound
  4. Injection technique: Injection into the lesion by investigator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in the size of rotator cuff tears determined by MRI
Time Frame: 12 months
12 months
Adverse event
Time Frame: 12 months
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)
Time Frame: 12 months
12 months
Muscle strength (lb)
Time Frame: 12 months
The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale
12 months
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
12 months
Blood Pressure (mmHg)
Time Frame: 12 months
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure
12 months
CBC(complete blood count)
Time Frame: 12 months
The measures are composite.
12 months
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.
12 months
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.
12 months
Blood Glucose
Time Frame: 12 months
Blood glucose levels are measured to assess glycemic control and detect hyperglycemia or hypoglycemia.
12 months
BUN/Creatinine Ratio
Time Frame: 12 months
The ratio of blood urea nitrogen (BUN) to creatinine is measured to evaluate kidney function.
12 months
Serum Total Protein
Time Frame: 12 months
Serum total protein levels are measured to evaluate overall protein status
12 months
Serum Albumin
Time Frame: 12 months
Serum albumin levels are measured to assess liver function, nutritional status, and oncotic pressure regulation.
12 months
Serum total bilirubin
Time Frame: 12 months
Serum total bilirubin levels are measured to evaluate liver function
12 months
Aspartate Transaminase/Alanine Transaminase(AST/ALT)
Time Frame: 12 months
AST and ALT levels are measured to assess liver function
12 months
Serum Alkaline Phosphatase(ALP)
Time Frame: 12 months
Serum ALP levels are measured to evaluate liver and bone health.
12 months
Serum Gamma-Glutamyl Transferase(γ-GTP)
Time Frame: 12 months
Serum γ-GTP levels are measured to assess liver function
12 months
Serum creatine kinase(CK)
Time Frame: 12 months
Serum creatine kinase levels are measured to assess muscle injury
12 months
Erythrocyte Sedimentation Rate(ESR)
Time Frame: 12 months
ESR is measured to assess inflammation or detect inflammatory conditions
12 months
C-Reactive Protein(CRP)
Time Frame: 12 months
Serum CRP levels are measured to evaluate acute inflammation
12 months
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.
12 months
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
12 months
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.
12 months
Urine Glucose
Time Frame: 12 months
Urine glucose levels are measured to detect glycosuria. Normal range is negative.
12 months
Urine Bilirubin
Time Frame: 12 months
Urine bilirubin levels are measured to assess liver function. Normal range is negative.
12 months
Urine Blood
Time Frame: 12 months
Urine blood levels are measured to detect hematuria. Normal range is negative
12 months
Urine Ketone
Time Frame: 12 months
Urine ketone levels are measured to detect ketonuria. Normal range is negative
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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