This trial is active, not recruiting.

Condition tennis elbow
Treatments allo-asc-ti, placebo
Phase phase 1/phase 2
Sponsor Anterogen Co., Ltd.
Start date January 2014
End date October 2014
Trial size 27 participants
Trial identifier NCT02131077, ALLO-ASC-TI-201


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
allo-asc-ti Allogenic adipose-derived stem cell
placebo 0.9% Saline

Primary Outcomes

time frame: Week 12
time frame: Week 12

Secondary Outcomes

VAS pain score
time frame: week 2, week 6 and week 12
VAS pain score
time frame: week 2, week 6 and week 12
Modified Mayo Clinic Performance Index
time frame: week 2, week 6 and week 12
Ultrasonic photography
time frame: week 6 and week 12

Eligibility Criteria

Male or female participants from 19 years up to 90 years old.

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 lesiom (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

Additional Information

Official title A Multi-center, Randomized, Placebo-controlled, Double-blind, Parallel-group, Phase I/II Clinical Study to Evaluate Safety and Efficacy of Allogeneic Adipose-derived Stem Cells for the Treatment of Lateral Epicondylitis
Principal investigator S G Chung, M.D., Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Anterogen Co., Ltd..