Rotator Cuff DiseaseNCT06817616
Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
A study testing Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell in people with Rotator Cuff Disease, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large 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?
- Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
- patients presenting with symptomatic cervical spine disorders.
- patients experiencing bilateral shoulder pain.
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- patients diagnosed with multiple arthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
- patients with neurological deficits.
- Pregnant or breastfeeding patients
- patients unwilling to use effective contraception during the study period.
- patients currently infected with HBV, HCV, or HIV, or those with a positive RPR test result.
- patients with severe conditions that may affect the study, including cardiovascular diseases, renal diseases, hepatic diseases, endocrine disorders, or malignancies.
- patients who are unable to comprehend the questionnaires used for study assessments, including the Visual Analog Scale (VAS), or those with communication difficulties due to psychiatric disorders.
- Any other cases deemed inappropriate for study participation by the investigator.
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, 1 recruiting
- Recruiting
Korea University Anamh Hospital
Seoul, Korea, 02841
+82-2-870-3246, eunmiahn@scorlab.kr
About this study
Official title: Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
- Conditions
- Rotator Cuff Disease
- Being tested
- Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection allogenic Umbilical Cord-derived Mesenchymal Stem CellBiological
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
- Injection dosage and volume of the study drugs:
- Low dose: 2.5X10 cells/0.5mL
- Number of injections: Only once during the study period
- Device: Ultrasound
- Injection technique: Injection into the lesion by investigator
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell
- Injection dosage and volume of the study drugs:
- High dose: 5X10 cells/1mL
- Number of injections: Only once during the study period
- Device: Ultrasound
- Injection technique: Injection into the lesion by investigator
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears | Experimental | Not described Receives: Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS) pain in motion
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: 12 months
Secondary outcomes (2)
Changes in the size of rotator cuff tears determined by MRI
Measured: 12 months
Adverse event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start17 Jan 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woong Kyo Jeong, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817616
- Sponsor's protocol ID
- KUAH-25-01
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT06817616
- Acronym / sponsor ID
- KUAH-25-01
- Conditions
- Rotator Cuff Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears | Experimental | Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- patients presenting with symptomatic cervical spine disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection allogenic Umbilical Cord-derived Mesenchymal Stem CellBiological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 2.5X10 cells/0.5mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: - High dose: 5X10 cells/1mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator | Biological | Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears |
Primary outcome
Visual Analog Scale(VAS) pain in motion
Time frame: 12 months
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.
2 secondary outcomes
Changes in the size of rotator cuff tears determined by MRI
Time frame: 12 months
Adverse event
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell in people with Rotator Cuff Disease, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Woong Kyo Jeong (82-10-4047-2878, drshoulder@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) pain in motion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.