Using stem cells to repair large rotator cuff tears

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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.

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• 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 from umbilical cords to treat 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.

  Recruiting Phase 1/2 Seoul National University Hospital · Seoul, Korea · NCT06794294

• 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.