Using stem cells from umbilical cords to treat rotator cuff disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Functional electrical stimulation plus shoulder exercises for older adults with rotator cuff pain

  In older adults with rotator cuff–related shoulder pain, this study tests whether adding functional electrical stimulation to a shoulder exercise program improves muscle coordination and reduces impingement compared with exercises alone.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07886827

• Long-Term Safety and Efficacy of Allogenic Umbilical Cord–Derived MSCs for Rotator Cuff Disease

  This long-term follow-up checks whether allogenic umbilical cord–derived mesenchymal stem cells are safe and helpful for people with rotator cuff disease who previously received the treatment.

  Recruiting Seoul National University Hospital · Seoul, Korea · NCT07374679

• Using stem cells to repair large 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.

  Recruiting Korea University Anam Hospital · Seoul, Korea · NCT06817616

• Understanding the significance of rotator cuff disease

  This study is trying to learn more about how rotator cuff disease affects patients by using shoulder questionnaires and exercise to see what improvements matter most to them.

  Recruiting Kırklareli University · Kırklareli · NCT06677320

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.