NCT06817616

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 4, 2025

Last Update Submit

February 17, 2025

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Changes in the size of rotator cuff tears determined by MRI

    12 months

  • Adverse event

    12 months

Other Outcomes (27)

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

    12 months

  • Muscle strength (lb)

    12 months

  • Pulse rate (beats per minute)

    12 months

  • +24 more other outcomes

Study Arms (1)

Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears

EXPERIMENTAL
Biological: Injection allogenic Umbilical Cord-derived Mesenchymal Stem Cell

Interventions

Injection allogenic Umbilical Cord-derived Mesenchymal Stem CellBIOLOGICAL

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

Patients diagnosed with Full-Thickness Rotator Cuff Tears, Including Massive and Large Tears

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anamh Hospital

Seoul, Korea, 02841, South Korea

RECRUITING

Central Study Contacts

Woong Kyo Jeong

CONTACT

82-10-4047-2878drshoulder@korea.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

January 17, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

KR(1)