Clinical trial NCT06794294: Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease
Official title: A Single Center, Open Label, Phase 1/2a Study to Evaluate Safety and Exploratory Efficacy of Allogenic Umbilical Cord Derived Mesenchymal Stem Cell Treatment in Patients with Rotator Cuff Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rotator Cuff Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 21
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: The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease


Eligibility criteria: 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

Primary outcomes:
measure: Shoulder pain and disability index(SPADI) Score
timeFrame: 6 months
Secondary outcomes:
measure: Constant-Murley score
timeFrame: 6 months
measure: Visual Analog Scale(VAS) pain in motion
timeFrame: 6 months
measure: Changes in the size of rotator cuff tears determined by MRI
timeFrame: 6 months
measure: Changes in the size of rotator cuff tears determined by arthroscopy
timeFrame: 6 months
measure: Adverse event
timeFrame: 6 months
Other outcomes:
measure: Change in degeneration score compared to baseline and the rate of change through histological examination
timeFrame: 6 months
measure: STR (Short tandem repeat) analysis
timeFrame: 6 months
measure: Visual Analog Scale_pain at night
timeFrame: 6 months
measure: Visual Analog Scale(VAS) worst pain
timeFrame: 6 months
measure: Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)
timeFrame: 6 months
measure: Muscle strength (lb)
timeFrame: 6 months
measure: Pulse rate (beats per minute)
timeFrame: 6 months
measure: Blood Pressure (mmHg)
timeFrame: 6 months
measure: CBC(complete blood count)
timeFrame: 6 months
measure: Usage amount of rescue medication
timeFrame: 6 months
measure: Frequency of rescue medication
timeFrame: 6 months
measure: Blood Glucose
timeFrame: 6 months
measure: BUN/Creatinine Ratio
timeFrame: 6 months
measure: Serum Total Protein
timeFrame: 6 months
measure: Serum Albumin
timeFrame: 6 months
measure: Serum total bilirubin
timeFrame: 6 months
measure: Aspartate Transaminase/Alanine Transaminase(AST/ALT)
timeFrame: 6 months
measure: Serum Alkaline Phosphatase(ALP)
timeFrame: 6 months
measure: Serum Gamma-Glutamyl Transferase(γ-GTP)
timeFrame: 6 months
measure: Serum creatine kinase(CK)
timeFrame: 6 months
measure: Erythrocyte Sedimentation Rate(ESR)
timeFrame: 6 months
measure: C-Reactive Protein(CRP)
timeFrame: 6 months
measure: Urine pH Levels
timeFrame: 6 months
measure: Urine Specific Gravity
timeFrame: 6 months
measure: Urine Protein
timeFrame: 6 months
measure: Urine Glucose
timeFrame: 6 months
measure: Urine Bilirubin
timeFrame: 6 months
measure: Urine Blood
timeFrame: 6 months
measure: Urine Ketone
timeFrame: 6 months
measure: Microscopic Analysis
timeFrame: 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
state: Korea
Study officials:
References: