Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Disease
• Intervention / Treatment: Biological: umbilical cord-derived mesenchymal stem cell; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyoung Hwan Koh; Phone Number: +82-2-3010-3530; Email: osdoc.koh@gmail.com

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 05505
      • Asan Medical Center
      • Contact: Sarah Hwang; Phone Number: +82-2-3010-8674; Email: tpfkzlxl@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Drug: Normal Saline; Administration of normal saline as a placebo control.
Experimental: High-dose group	Biological: umbilical cord-derived mesenchymal stem cell; Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
Experimental: Medium-Dose Group	Biological: umbilical cord-derived mesenchymal stem cell; Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6months
Location and size of the rotator cuff tear assessed by arthroscopy		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.	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.	6months
Amount and frequency of rescue medication use		6months
Adverse events		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	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.	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.	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.	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	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.	6months
Urinalysis	- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination	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	6months

Collaborators and Investigators

• Sponsor: Kyoung Hwan Koh

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: R-3-0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No