A Phase 2 interventional study of High concentration of Allo-ASC and Low concentration of Allo-ASC in Lateral Epicondylitis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment
The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patients in comparison with a control treatment.
A phase II randomized placebo controlled trial will be done with following 3 groups. Each group will have 10 participants, so, the total patients will be 30 people.
Exclusion Criteria:
High concentration of Allo-ASC 0.5cc (Total: 10 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Biological: High concentration of Allo-ASC · Drug: Fibrin glue
Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Biological: Low concentration of Allo-ASC · Drug: Fibrin glue
Normal saline 0.5cc \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Drug: Fibrin glue · Drug: Normal saline
10 million cells of Allo-ASC 0.5cc
1 million cells of Allo-ASC 0.5cc
Fibrin glue 0.5cc
Also known as: Fibrin sealant
Normal saline 0.5cc
Also known as: 0.9% Sodium Chloride Solution
Change of pain visual analogue scale (VAS) during activity
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time frame: baseline and 12 weeks
Change of pain visual analogue scale (VAS) during activity
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Change of pain visual analogue scale (VAS) at rest
Self reported pain intensity at rest will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Change of Mayo elbow performance index (MEPI)
The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)
Time frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Ultrasonographic assessment
Ultrasonographic findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). Sonographic images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.
Time frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Shear wave elastography
Young modulus and shear wave speed will be obtained
Time frame: baseline, 12 weeks and 24 months
Magnetic resonance image (MRI) assessment
MRI findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). MR images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.
Time frame: baseline, 12 weeks and 24 months
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital