Clinical trial NCT06817616: Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears
Official title: Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Disease
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety Analysis of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients Undergoing Rotator Cuff Repair for Massive or Large Rotator Cuff Tears


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 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.

Primary outcomes:
measure: Visual Analog Scale(VAS) pain in motion
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the size of rotator cuff tears determined by MRI
timeFrame: 12 months
measure: Adverse event
timeFrame: 12 months
Other outcomes:
measure: Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)
timeFrame: 12 months
measure: Muscle strength (lb)
timeFrame: 12 months
measure: Pulse rate (beats per minute)
timeFrame: 12 months
measure: Blood Pressure (mmHg)
timeFrame: 12 months
measure: CBC(complete blood count)
timeFrame: 12 months
measure: Usage amount of rescue medication
timeFrame: 12 months
measure: Frequency of rescue medication
timeFrame: 12 months
measure: Blood Glucose
timeFrame: 12 months
measure: BUN/Creatinine Ratio
timeFrame: 12 months
measure: Serum Total Protein
timeFrame: 12 months
measure: Serum Albumin
timeFrame: 12 months
measure: Serum total bilirubin
timeFrame: 12 months
measure: Aspartate Transaminase/Alanine Transaminase(AST/ALT)
timeFrame: 12 months
measure: Serum Alkaline Phosphatase(ALP)
timeFrame: 12 months
measure: Serum Gamma-Glutamyl Transferase(γ-GTP)
timeFrame: 12 months
measure: Serum creatine kinase(CK)
timeFrame: 12 months
measure: Erythrocyte Sedimentation Rate(ESR)
timeFrame: 12 months
measure: C-Reactive Protein(CRP)
timeFrame: 12 months
measure: Urine pH Levels
timeFrame: 12 months
measure: Urine Specific Gravity
timeFrame: 12 months
measure: Urine Protein
timeFrame: 12 months
measure: Urine Glucose
timeFrame: 12 months
measure: Urine Bilirubin
timeFrame: 12 months
measure: Urine Blood
timeFrame: 12 months
measure: Urine Ketone
timeFrame: 12 months
measure: Microscopic Analysis
timeFrame: 12 months
measure: Number of participants with treatment-related adverse events as assessed by NCI - CTCAE v4.0
timeFrame: 12 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anamh Hospital
state: Korea
Study officials:
References: