Lateral Epicondylitis
Conditions
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell
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
Interventions
BIOLOGICALHigh concentration of Allo-ASC
10 million cells of Allo-ASC 0.5cc
BIOLOGICALLow concentration of Allo-ASC
1 million cells of Allo-ASC 0.5cc
DRUGFibrin glue
Fibrin glue 0.5cc
DRUGNormal saline
Normal saline 0.5cc
Sponsors
Korea Health Industry Development Institute
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
| 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). |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed