Using stem cells from umbilical cords to treat rotator cuff disease
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
This study is testing if injections of stem cells from umbilical cords can help people with rotator cuff disease who haven't found relief from other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Korea) |
| Trial ID | NCT06794294 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of allogenic umbilical cord-derived mesenchymal stem cells in patients suffering from rotator cuff disease. Participants will receive injections of these stem cells to assess their potential in alleviating shoulder pain and improving function. The study targets individuals who have not found relief from conservative treatments and have confirmed partial-thickness rotator cuff tears. It aims to provide a novel therapeutic option for those with chronic shoulder pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with unilateral shoulder pain lasting over three months and confirmed partial-thickness rotator cuff tears.
Not a fit: Patients with complete rotator cuff tears or those who have had recent shoulder surgeries or injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients with persistent rotator cuff disease who have not responded to traditional therapies.
How similar studies have performed: While the use of stem cells in orthopedic conditions is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Korea
- Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine — Seoul, Korea, South Korea (Recruiting)
Study contacts
- Study coordinator: KeeJeong Bae, Principal Investigator
- Email: grant903@gmail.com
- Phone: +82-10-5202-7469
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.