Arthroscopic Rotator Cuff Repair with UC-MSCs for Large to Massive Tears

ConditionRotator Cuff Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorKorea University Anam Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell
Biological/Vaccine
Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: * Low dose: 2.5X10 cells/0.5mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator Biological: Allogenic Umbilical Cord - derived Mesenchymal Stem Cell 1. Injection dosage and volume of the study drugs: \- High dose: 5X10 cells/1mL 2. Number of injections: Only once during the study period 3. Device: Ultrasound 4. Injection technique: Injection into the lesion by investigator

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large TearsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Visual Analog Scale(VAS) pain in motion

Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Time frame

12 months

Secondary outcomes

Changes in the size of rotator cuff tears determined by MRI

Time frame

12 months

Adverse event

Time frame

12 months

Other outcomes

Shoulder ROM (Forward flexion, Abduction, External rotation & Internal rotation at 0 degree)

Time frame

12 months

Muscle strength (lb)

The strength the supraspinatus, infraspinatus,and subscapularis was measured using a handheld electronic scale

Time frame

12 months

Pulse rate (beats per minute)

To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using pulse rate

Time frame

12 months

Blood Pressure (mmHg)

To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using blood pressure

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Source ClinicalTrials.gov

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