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Completed

NCT Number: NCT01856140

Treatment of Tendon Injury Using Mesenchymal Stem Cells

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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Seoul National University College of Medicine

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

Biological

Primary outcomes

  1. Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks

    Time frame: Baseline, 6 weeks, 12 weeks after intervention

    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 outcomes

  1. Modified Mayo Clinic Performance Index for the Elbow

    Time frame: Baseline, 6 weeks, 12 weeks after the intervention

    The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function.

  2. Defect Area of Tendon by Ultrasonography in Long Axis

    Time frame: Baseline, 6 weeks, and 12 weeks after the intervention

    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.

  3. Defect Area of Tendon by Ultrasonography in Short Axis

    Time frame: Baseline, 6 weeks, and 12 weeks after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Medical Research Collaborating Center, Seoul, Korea

Registry information

Official study title

Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study

Acronym: ALLO-ASC

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
May 17, 2013
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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