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

N/ANot Yet RecruitingNCT07605559

Kyoung Hwan Koh38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 6months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6months

Location and size of the rotator cuff tear assessed by arthroscopy

Central Contacts

Kyoung Hwan Koh

CONTACT

+82-2-3010-3530 osdoc.koh@gmail.com

Data from ClinicalTrials.gov

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