Rotator Cuff DiseasePhase 1/2NCT06794294
Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease
A Phase 1/2 study testing Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell in people with Rotator Cuff Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease 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
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2025to Jan 2027
- Phase
- Phase 1/2
- 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.
- Patients with unilateral shoulder pain lasting for at least 3months
- Patients who do not respond to conservative treatment.
- Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months
- Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
- Patients without any restrictions on clinical trial procedures, including hospitalization.
Who cannot join
- Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.
- Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months
- Patients with a history of receiving stem cell therapy for the shoulder.
- Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.
- Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.
- Patients presenting with symptomatic cervical spine disorders.
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- Patients with concurrent bilateral shoulder pain
- Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
- Patients with neurological deficit
- Pregnant women or lactating mothers.
- Patients unwilling to use effective contraception during the clinical trial period.
- Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test.
- Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies.
- Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication.
- Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules.
- Patients who have participated in another clinical trial within the last 3 months.
- Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion
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
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, 07061
Clinical Research Coordinator, +82-2-870-3246, eunmiahn@scorlab.kr
About this study
Official title: A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
- 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: 1x10⁷ cells/3mL
- 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:
- Mid dose: 5x10⁷ cells/3mL
- 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: 1x10e8 cells/3mL
- 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 partial-thickness rotator cuff tear | 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.
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: 6 months
Secondary outcomes (5)
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: 6 months
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: 6 months
Changes in the size of rotator cuff tears determined by MRI
Measured: 6 months
Changes in the size of rotator cuff tears determined by arthroscopy
Measured: 6 months
Adverse event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start17 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794294
- Sponsor's protocol ID
- ASB-IP-001
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2025
- Last updated
- 29 Apr 2026
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients With Rotator Cuff Disease
- ClinicalTrials.gov ID
- NCT06794294
- Acronym / sponsor ID
- ASB-IP-001
- Conditions
- Rotator Cuff Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jan 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.
The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease
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 partial-thickness rotator cuff tear | 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 (6 listed)
- Male or female 19 years of age and older.
- Patients with unilateral shoulder pain lasting for at least 3months
- Patients who do not respond to conservative treatment.
- Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months
- Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
Key exclusion criteria (17 listed)
- Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.
- Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months
- Patients with a history of receiving stem cell therapy for the shoulder.
- Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.
- Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.
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: 1x10⁷ cells/3mL 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: * Mid dose: 5x10⁷ cells/3mL 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: 1x10e8 cells/3mL 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 partial-thickness rotator cuff tear |
Primary outcome
Shoulder pain and disability index(SPADI) Score
Time frame: 6 months
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.
5 secondary outcomes
Constant-Murley score
Time frame: 6 months
Visual Analog Scale(VAS) pain in motion
Time frame: 6 months
Changes in the size of rotator cuff tears determined by MRI
Time frame: 6 months
Changes in the size of rotator cuff tears determined by arthroscopy
Time frame: 6 months
Adverse event
Time frame: 6 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 29 Apr 2026.
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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 Phase 1/2 study testing Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell in people with Rotator Cuff Disease, run by Seoul National University 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 6 inclusion and 17 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 29 Apr 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 KeeJeong Bae, Principal Investigator (+82-10-5202-7469, grant903@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain and disability index(SPADI) Score (time frame: 6 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 29 Apr 2026.