Back to resultsTreatment of Tendon Injury Using Mesenchymal Stem Cells (ALLO-ASC)
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring adipose derived mesenchymal stem cell, allogeneic stem cell
Eligibility Criteria
Inclusion Criteria:
- clinically diagnosed as lateral epicondylitis (tennis elbow)
- recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- symptom duration is over 6 months
- defect in common extensor tendon can be observed under ultrasound
- patient that can understand the clinical trials
Exclusion Criteria:
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- patient that enrolled other clinical trials within 30 days
- history of drug/alcohol addiction, habitual smoker
Sites / Locations
- Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 million cells/ml of ALLO-ASC
10 million cells/ml of ALLO-ASC
Arm Description
1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
Outcomes
Primary Outcome Measures
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.
Secondary Outcome Measures
Modified Mayo Clinic Performance Index for the Elbow
The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function.
Defect Area of Tendon by Ultrasonography in Long Axis
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Defect Area of Tendon by Ultrasonography in Short Axis
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Full Information
NCT ID
NCT01856140
First Posted
April 26, 2013
Last Updated
February 21, 2022
Sponsor
Seoul National University Hospital
Collaborators
Medical Research Collaborating Center, Seoul, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01856140
Brief Title
Treatment of Tendon Injury Using Mesenchymal Stem Cells
Acronym
ALLO-ASC
Official Title
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Medical Research Collaborating Center, Seoul, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.
Detailed Description
Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).
The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 million cells/ml of ALLO-ASC
Arm Type
Experimental
Arm Description
1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
Arm Title
10 million cells/ml of ALLO-ASC
Arm Type
Active Comparator
Arm Description
10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
Intervention Type
Biological
Intervention Name(s)
ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Primary Outcome Measure Information:
Title
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
Description
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.
Time Frame
Baseline, 6 weeks, 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Modified Mayo Clinic Performance Index for the Elbow
Description
The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function.
Time Frame
Baseline, 6 weeks, 12 weeks after the intervention
Title
Defect Area of Tendon by Ultrasonography in Long Axis
Description
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Time Frame
Baseline, 6 weeks, and 12 weeks after the intervention
Title
Defect Area of Tendon by Ultrasonography in Short Axis
Description
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Time Frame
Baseline, 6 weeks, and 12 weeks after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinically diagnosed as lateral epicondylitis (tennis elbow)
recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
symptom duration is over 6 months
defect in common extensor tendon can be observed under ultrasound
patient that can understand the clinical trials
Exclusion Criteria:
patient that underwent other injection treatment within 6 weeks
some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
patient that enrolled other clinical trials within 30 days
history of drug/alcohol addiction, habitual smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Gun Chung, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
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20970844
Citation
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Treatment of Tendon Injury Using Mesenchymal Stem Cells
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