NCT02131077CompletedPhase 1
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
Anterogen Co., Ltd.6 sites in 1 country30 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
treatment
Experimental
ALLO-ASC-TI injection
Intervention: ALLO-ASC-TI (Biological)
Placebo
Placebo Comparator
Saline injection
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Efficacy
Time Frame: Week 12
Improvement of VAS pain score at 12 weeks compared to baseline per each group
Secondary Outcomes
- VAS pain score(week 2, week 6 and week 12)
- Ultrasonic photography(week 6 and week 12)
- Safety(Week 12)
- Improvement rate of VAS pain score(week 2, week 6 and week 12)
- Modified Mayo Clinic Performance Index(week 2, week 6 and week 12)
Investigators
Study Sites (6)
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