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 enrollmentJanuary 2014

ConditionsTennis Elbow

InterventionsALLO-ASC-TI Placebo

DrugsPlacebo

Overview

Phase: Phase 1
Intervention: ALLO-ASC-TI
Conditions: Tennis Elbow
Sponsor: Anterogen Co., Ltd.
Enrollment: 30
Locations: 6
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anterogen Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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