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. 1. High concentration of Allo-ASC group: stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc 2. Low concentration of Allo-ASC group: stem cell 0.5cc (Total: 1 million cells) + Fibrin glue 0.5cc 3. Placebo Comparator (Fibrin) group: Normal saline 0.5cc + Fibrin glue 0.5cc The investigators will compare the efficacy difference with visual analogue scale (VAS) during activity (primary outcome), VAS at rest, Mayo elbow performance index (MEPI), grip strength, ultrasonographic assessment at baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months after injection. Shear wave elastography (SWE) and magnetic resonance image (MRI) will be done at baseline, 12 weeks, 12 months and 24 months after injection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
10 million cells of Allo-ASC 0.5cc
1 million cells of Allo-ASC 0.5cc
Fibrin glue 0.5cc
Seoul National University Hospital
Seoul, South Korea
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
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Normal saline 0.5cc
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