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New treatment option for Rotator Cuff Disease
Official title Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease
ClinicalTrials.gov ID: NCT06794294
What this study is testing
What is Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell?
Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rotator cuff disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
You likely can't join if
- 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...
- Patients presenting with symptomatic cervical spine disorders.
See the full eligibility criteria
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Korea, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Korea, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.