Using stem cells to repair large rotator cuff tears
Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
This study is testing whether injections of stem cells from umbilical cords can help people with large rotator cuff tears recover better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul, Korea) |
| Trial ID | NCT06817616 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety of using allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in patients undergoing arthroscopic repair for large to massive rotator cuff tears. Participants must be experiencing significant shoulder pain and have not found relief from conventional treatments. The study aims to assess the effectiveness of stem cell injections in enhancing recovery and healing in these patients. The trial is focused on individuals with confirmed extensive rotator cuff injuries as diagnosed by imaging techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with unilateral shoulder pain and extensive rotator cuff tears that have not responded to standard treatments.
Not a fit: Patients with small or medium rotator cuff tears or those who have had recent shoulder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and recovery for patients with large rotator cuff tears.
How similar studies have performed: While the use of stem cells in orthopedic applications is gaining interest, this specific approach for rotator cuff repair is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
Seoul, Korea
- Korea University Anamh Hospital — Seoul, Korea, South Korea (Recruiting)
Study contacts
- Study coordinator: Woong Kyo Jeong
- Email: drshoulder@korea.ac.kr
- Phone: 82-10-4047-2878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.