Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tennis Elbow

Intervention / Treatment
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* Biological: ALLO-ASC-TI
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 19 years. Patients who are diagnosed as lateral epicondylitis (Pain≥4 of VAS during activity). Patients who has sustained pain more than 6 months Patients who lasting for pain in spite of conservative therapy Patients who have one lesion under ultrasonic photography Negative for urine beta-HCG for women of childbearing age Patient who is able to give written informed consent prior to study start and to comply with the study requirements Exclusion Criteria: Patients who has been experienced steroid and prolotherapy or other treatment within 3 months at screening time Patients who have lesion size of width and length more than 1 cm using ultrasonic photography test 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 Patients who are pregnant or breast-feeding Patients who have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue Patients who have history of fracture and dislocation at Ipsilateral upper extremity within 2 years recently Patients who have operation history in tendon, ligament and bone at Ipsilateral upper extremity within 2 years recently Patients who are unwilling to use an effective method of contraception during the study Patients who have a clinically relevant history of abuse of alcohol or drugs Patients who are considered not suitable for the study by investigator Patients who have experienced treatment with stem cell before this study Patients who currently enrolled in another investigational drug study within 30 days of screening

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>ALLO-ASC-TI injection | Biological: ALLO-ASC-TI<br> <br> * Other names: Allogenic adipose-derived stem cell;|
| Placebo Comparator: Placebo<br>Saline injection | Drug: Placebo<br> <br> * Other names: 0.9% Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Improvement of VAS pain score at 12 weeks compared to baseline per each group | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score | Changes in the VAS pain score during activity per each group | week 2, week 6 and week 12 | 
| Improvement rate of VAS pain score | Improvement rate of VAS pain score at rest per each group | week 2, week 6 and week 12 | 
| Modified Mayo Clinic Performance Index | Change in Modified Mayo Clinic Performance Index per each group | week 2, week 6 and week 12 | 
| Ultrasonic photography | Change in analysis of lesion size per each group | week 6 and week 12 | 
| Safety | Clinically measured abnormality of laboratory tests and adverse events | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Epicondylitis