Recruiting

Umbilical Cord Stem Cells for Large Rotator Cuff Tear Repair

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What is being tested

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Biological
Who is being recruted

Over 19 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorKorea University Anam Hospital
Study ContactWoong Kyo Jeong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 17, 2025

Actual date on which the first participant was enrolled.

This study explores the safety of using mesenchymal stem cells derived from umbilical cords as part of a treatment for individuals with large to massive tears in their rotator cuff, a group of muscles and tendons that stabilize the shoulder. The study is aimed at people undergoing an arthroscopic procedure to repair these tears. Rotator cuff tears can severely impact shoulder function and quality of life, so finding effective treatments is crucial. The use of stem cells in this context is being investigated because they have the potential to enhance healing and tissue regeneration, which could lead to better recovery outcomes for patients. Participants in the study will receive an injection of umbilical cord-derived mesenchymal stem cells during their rotator cuff repair surgery. The study will focus on evaluating the safety of this treatment approach by monitoring participants for any adverse effects that may occur. By carefully assessing how well patients tolerate the stem cell treatment, the study aims to gather valuable data that could pave the way for improved therapies for rotator cuff injuries.

Official TitleArthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
NCT06817616
Principal SponsorKorea University Anam Hospital
Study ContactWoong Kyo Jeong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
14 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Korea University Anamh Hospital

Seoul, South KoreaOpen Korea University Anamh Hospital in Google Maps
Recruiting
One Study Center