Clinical trial NCT02131077: Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tennis Elbow
Keywords: Lateral Epicondylitis
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Efficacy
timeFrame: Week 12
Secondary outcomes:
measure: VAS pain score
timeFrame: week 2, week 6 and week 12
measure: Improvement rate of VAS pain score
timeFrame: week 2, week 6 and week 12
measure: Modified Mayo Clinic Performance Index
timeFrame: week 2, week 6 and week 12
measure: Ultrasonic photography
timeFrame: week 6 and week 12
measure: Safety
timeFrame: Week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptal
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Nanoori hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: S G Chung, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: