Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis
NCT ID: NCT02131077
Last Updated: 2016-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2014-01-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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treatment
ALLO-ASC-TI injection
ALLO-ASC-TI
Placebo
Saline injection
Placebo
Interventions
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ALLO-ASC-TI
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are diagnosed as lateral epicondylitis (Painā„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
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
19 Years
90 Years
ALL
No
Sponsors
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Anterogen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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S G Chung, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hosptal
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Nanoori hospital
Seoul, , South Korea
Samsung medical center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ALLO-ASC-TI-201
Identifier Type: -
Identifier Source: org_study_id