Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
Recruiting
N/AInterventional Study
Rotator Cuff Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Korea University Anam Hospital · Other
Who this trial is looking for
This trial is looking for people aged 19 and older with shoulder pain from large or massive rotator cuff tears that have not improved with regular treatments. Participants will receive treatment involving stem cells from umbilical cord tissue while undergoing surgery to repair their rotator cuff.
I have shoulder pain with a pain score of 4 or higher.
My shoulder pain has lasted at least three months.
I have not responded to conventional treatments, including pain relievers.
I have been diagnosed with a massive or extensive full-thickness rotator cuff tear.
You may not be able to join if
I have a small or medium full-thickness rotator cuff tear.
I have had a shoulder injection therapy in the last three months.
I have had rotator cuff surgery on my shoulder in the last six months.
I have certain serious problems like tumors or severe arthritis.
I have symptoms of cervical spine disorders.
I have pain in both shoulders.
I have conditions like rheumatoid arthritis or fibromyalgia.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears
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Eligibility 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 exten…
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.
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