Starting soon
Not applicable
Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
Condition(s) studied
Rotator Cuff Disease
Investigational drug(s) / intervention(s)
umbilical cord-derived mesenchymal stem cellNormal Saline
umbilical cord-derived mesenchymal stem cell: Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells
Normal Saline: Administration of normal saline as a placebo control.
Study summary
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
Eligibility
Inclusion Criteria:
* Adults aged 19 years or older
* Shoulder pain lasting for at least 3 months
* A pain visual analogue scale (VAS) score of 4 or greater
* Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy
* Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI)
* No restrictions on participation in clinical trial procedures, including hospitalization
Exclusion Criteria:
* Receipt of subacromial injection therapy in the affected shoulder within the past 3 months
* History of rotator cuff surgery on the affected shoulder within the past 6 months
* Previous treatment with a stem cell therapy for the shoulder
* Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months
* Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury
* Presence of symptomatic cervical spine disease
* Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
* Clinical trial subjects with neurological deficits
* Pregnant or breastfeeding women
* Unwillingness to use an effective method of contraception during participation in the clinical trial
* Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease
* Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness
* Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule
* Participation in another clinical trial within 3 months prior to enrollment in this clinical trial
* Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial
Primary outcome measure(s)
- Changes in the size of rotator cuff tears determined by MRI — 6months
The location, width (AP size), length (ML size), and depth of the rotator cuff tear will be measured on oblique coronal, axial, and sagittal MRI images where the tear is most clearly visualized. The same measurements will be performed on the corresponding planes after administration of the investigational product and compared with those obtained before administration.
Trial sites (1)
| Facility | City | Region | Status |
| Asan Medical Center |
Seoul |
Seoul |
|
Other trials for the same condition