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Recruiting NCT06817616

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

No phase Interventional Rotator Cuff Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell.
Who it may be relevant to
Registry conditions: Rotator Cuff Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Biological Injection 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

Primary outcome measures

  • Visual Analog Scale(VAS) pain in motion [Time frame: 12 months]
Secondary outcome measures (2)
  • Changes in the size of rotator cuff tears determined by MRI [Time frame: 12 months]
  • Adverse event [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Korea University Anamh Hospital — Seoul

Identifiers

NCT: NCT06817616 · KUAH-25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗