Tennis Elbow
Conditions
Keywords
Lateral Epicondylitis
Brief summary
The objective of this study is to evaluate the safety and efficacy of allogeneic adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.
Interventions
BIOLOGICALALLO-ASC-TI
DRUGPlacebo
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Older than 19 years. 2. Patients who are diagnosed as lateral epicondylitis (Pain≥4 of VAS during activity). 3. Patients who has sustained pain more than 6 months 4. Patients who lasting for pain in spite of conservative therapy 5. Patients who have one lesion under ultrasonic photography 6. Negative for urine beta-HCG for women of childbearing age 7. Patient who is able to give written informed consent prior to study start and to comply with the study requirements
Exclusion criteria
1. Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time 2. Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test 3. Patients who were accompanied by the disease as follows: A. Arthritis of related joint to the target lesion (ex, cubital osteo- arthritis), B.Synovitis of related joint to the target lesion, C.Entrapment of related nerve to the target lesion(ex, radial tunnel syndrome), D.Generalized pain syndrome, E.Radiculopathy related to the target lesion(ex, cervical spodylosis ,cervical radicular syndrome), F.Rheumatoid arthritis, G.Previous fracture of arm causing limitations in arm function, H.Impaired sensibility, I.Paralysis 4. Patients who are pregnant or breast-feeding 5. Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue 6. Patients who have history of fracture and dislocation at Ipsilateral upper extremity within 2 years recently 7. Patients who have operation history in tendon, ligament and bone at Ipsilateral upper extremity within 2 years recently 8. Patients who are unwilling to use an effective method of contraception during the study 9. Patients who have a clinically relevant history of abuse of alcohol or drugs 10. Patients who are considered not suitable for the study by investigator 11. Patients who have experienced treatment with stem cell before this study 12. Patients who currently enrolled in another investigational drug study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Week 12 | Improvement of VAS pain score at 12 weeks compared to baseline per each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain score | week 2, week 6 and week 12 | Changes in the VAS pain score during activity per each group |
| Improvement rate of VAS pain score | week 2, week 6 and week 12 | Improvement rate of VAS pain score at rest per each group |
| Modified Mayo Clinic Performance Index | week 2, week 6 and week 12 | Change in Modified Mayo Clinic Performance Index per each group |
| Ultrasonic photography | week 6 and week 12 | Change in analysis of lesion size per each group |
| Safety | Week 12 | Clinically measured abnormality of laboratory tests and adverse events |
Countries
South Korea
Outcome results
None listed