RecruitingNot ApplicableNCT06817616

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

Arthroscopic Rotator Cuff Repair with Umbilical Cord-derived Mesenchymal Stem Cells for Large to Massive Rotator Cuff Tears


Sponsor

Korea University Anam Hospital

Enrollment

15 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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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Interventions

BIOLOGICALInjection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

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


Locations(1)

Korea University Anamh Hospital

Seoul, Korea, South Korea

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NCT06817616


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