Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)
- Conditions
- Lateral Epicondylitis
- Interventions
- Biological: High concentration of Allo-ASCBiological: Low concentration of Allo-ASCDrug: Normal saline
- Registration Number
- NCT03449082
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- clinically diagnosed as lateral epicondylosis (tennis elbow)
- symptom duration is over 12 months
- pain visual analogue scale (VAS) during activity ≥ 5
- recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)
- patient that can understand the clinical trials
- patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks
- patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)
- patient that enrolled other clinical trials within 30 days
- current pregnancy or breast-feeding, planning for pregnancy
- history of drug/alcohol addiction, habitual smoker
- operation history of affected elbow
- previous clinical trial involving stem cell administration
- other severe medical illness or bleeding tendency
- size of intramural calcification over 2.0 mm under ultrasound evaluation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High concentration of Allo-ASC group Fibrin glue High concentration of Allo-ASC 0.5cc (Total: 10 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection High concentration of Allo-ASC group High concentration of Allo-ASC High concentration of Allo-ASC 0.5cc (Total: 10 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection Low concentration of Allo-ASC group Low concentration of Allo-ASC Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection Low concentration of Allo-ASC group Fibrin glue Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection Placebo Comparator (Fibrin) group Fibrin glue Normal saline 0.5cc \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection Placebo Comparator (Fibrin) group Normal saline Normal saline 0.5cc \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
- Primary Outcome Measures
Name Time Method Change of pain visual analogue scale (VAS) during activity baseline 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).
- Secondary Outcome Measures
Name Time Method Change of Mayo elbow performance index (MEPI) baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)
Ultrasonographic assessment baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months 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.
Shear wave elastography baseline, 12 weeks and 24 months Young modulus and shear wave speed will be obtained
Magnetic resonance image (MRI) assessment baseline, 12 weeks and 24 months 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.
Change of pain visual analogue scale (VAS) during activity baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Change of pain visual analogue scale (VAS) at rest baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months Self reported pain intensity at rest will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of