Rotator Cuff DiseaseNCT07605559
Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
A study testing umbilical cord-derived mesenchymal stem cell and Normal Saline in people with Rotator Cuff Disease, run by Kyoung Hwan Koh at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- umbilical cord-derived mesenchymal stem cell and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Shoulder pain lasting for at least 3 months
- A pain visual analogue scale (VAS) score of 4 or greater
- Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy
- Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI)
- No restrictions on participation in clinical trial procedures, including hospitalization
Who cannot join
- Receipt of subacromial injection therapy in the affected shoulder within the past 3 months
- History of rotator cuff surgery on the affected shoulder within the past 6 months
- Previous treatment with a stem cell therapy for the shoulder
- Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months
- Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury
- Presence of symptomatic cervical spine disease
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- Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- Clinical trial subjects with neurological deficits
- Pregnant or breastfeeding women
- Unwillingness to use an effective method of contraception during participation in the clinical trial
- Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease
- Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness
- Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule
- Participation in another clinical trial within 3 months prior to enrollment in this clinical trial
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan Medical Center
Seoul, Seoul, 05505
Sarah Hwang, +82-2-3010-8674, tpfkzlxl@naver.com
About this study
Official title: A Multi-center Study on Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
- Conditions
- Rotator Cuff Disease
- Being tested
- umbilical cord-derived mesenchymal stem cell, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord-derived mesenchymal stem cellBiological
Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
Normal SalineDrug
Administration of normal saline as a placebo control.
| Study group | Role | What they receive |
|---|---|---|
| High-dose group | Experimental | Not described Receives: Biological: umbilical cord-derived mesenchymal stem cell |
| Medium-Dose Group | Experimental | Not described Receives: Biological: umbilical cord-derived mesenchymal stem cell |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the size of rotator cuff tears determined by MRI
The location, width (AP size), length (ML size), and depth of the rotator cuff tear will be measured on oblique coronal, axial, and sagittal MRI images where the tear is most clearly visualized. The same measurements will be performed on the corresponding planes after administration of the investigational product and compared with those obtained before administration.
Measured: 6months
Secondary outcomes (16)
Shoulder pain and disability index(SPADI) Score
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.
Measured: 6months
Constant-Murley score
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.
Measured: 6months
Visual Analog Scale(VAS) pain
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.
Measured: 6months
Location and size of the rotator cuff tear assessed by arthroscopy
Measured: 6months
Histological Evaluation of Tendon Tissue
If tendon regeneration at the lesion site is confirmed by arthroscopic examination before and after administration of the investigational product, a tissue sample approximately 2 mm in diameter will be collected from the regenerated area and evaluated using the modified Astrom and Movin scoring system.
Measured: 6months
Short tandem repeat (STR) evaluation of tendon tissue
STR testing will be performed using a portion of the collected tendon tissue. The results will be compared with those of the investigational product and the clinical study participant's blood to evaluate the origin of the regenerated tendon tissue.
Measured: 6months
Amount and frequency of rescue medication use
Measured: 6months
Adverse events
Measured: 6months
Height
The investigator will perform physical examinations according to the clinical study schedule, based on medical judgment. Height will be measured only at Visit 1. Height will be measured in centimeters
Measured: Visit 1
Weight
The investigator will perform physical examinations at each visit according to the clinical study schedule, based on medical judgment. Body weight will be measured in kilograms at each visit.
Measured: 6months
Systolic and Diastolic blood pressure
The investigator will check systolic and diastolic blood pressure at each visit according to the clinical study schedule, based on medical judgment.systolic and diastolic blood pressure will be measured in a seated position.
Measured: 6months
Pulse rate
The investigator will check pulse rate at each visit according to the clinical study schedule, based on medical judgment. Pulse rate will be measured in a seated position.
Measured: 6months
Complete blood count
Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water.
- WBC, RBC, hemoglobin, hematocrit, platelets, and differential count
Measured: 6months
Serum chemistry test
- general: glucose, BUN/creatinine, total protein, albumin, total bilirubin, AST/ALT, ALP, γ-GTP, CK, ESR, CRP
Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water.
Measured: 6months
Urinalysis
- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination
Measured: 6months
Alloimmune test
Clinical study participants will visit the study site at Visit 2 (treatment) and Visit 3 (exploratory efficacy and safety assessment) to undergo alloimmune testing.
- Antigen test: HLA-A, HLA-B, HLA-DR
- Antibody test: PRA-I, PRA-II
If a positive response is observed in the PRA test, the following additional tests will be performed:
- HLA Single Ag I, HLA Single Ag II
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoung Hwan Koh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyoung Hwan Koh, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605559
- Sponsor's protocol ID
- R-3-0023
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No