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

NCT07605559 | Not Yet Recruiting

• 1 other identifier: R-3-0023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Shoulder pain and disability index(SPADI) Score

  6months

• Constant-Murley score

  6months

• Visual Analog Scale(VAS) pain

  6months

• Location and size of the rotator cuff tear assessed by arthroscopy

  6months

• Histological Evaluation of Tendon Tissue

  6months

Study Arms (3)

High-dose group

EXPERIMENTAL

Biological: umbilical cord-derived mesenchymal stem cell

Medium-Dose Group

EXPERIMENTAL

Biological: umbilical cord-derived mesenchymal stem cell

Placebo Comparator

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

umbilical cord-derived mesenchymal stem cell BIOLOGICAL

Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells

High-dose group; Medium-Dose Group

Normal Saline DRUG

Administration of normal saline as a placebo control.

Placebo Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoung Hwan Koh: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Kyoung Hwan Koh

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)