NCT06794294 Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease
| NCT ID | NCT06794294 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | Rotator Cuff Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2025-01-17 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06794294 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Rotator Cuff Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06794294 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06794294 currently recruiting?
Yes, NCT06794294 is actively recruiting participants. Contact the research team at grant903@gmail.com for enrollment information.
Where is the NCT06794294 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06794294 clinical trial?
NCT06794294 is sponsored by Seoul National University Hospital. The trial plans to enroll 21 participants.