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Recruiting NCT06794294

Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients With Rotator Cuff Disease

Phase I / Phase II 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

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

Overview

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

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: 1x10⁷ cells/3mL 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: * Mid dose: 5x10⁷ cells/3mL 2. Number of injections: Only once during the

Primary outcome measures

  • Shoulder pain and disability index(SPADI) Score [Time frame: 6 months]
Secondary outcome measures (5)
  • Constant-Murley score [Time frame: 6 months]
  • Visual Analog Scale(VAS) pain in motion [Time frame: 6 months]
  • Changes in the size of rotator cuff tears determined by MRI [Time frame: 6 months]
  • Changes in the size of rotator cuff tears determined by arthroscopy [Time frame: 6 months]
  • Adverse event [Time frame: 6 months]

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

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
  • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Se — Seoul

Identifiers

NCT: NCT06794294 · ASB-IP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗