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

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ClinicalTrials.gov Identifier: NCT02131077
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Biological: ALLO-ASC-TI Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment
ALLO-ASC-TI injection
 Biological: ALLO-ASC-TI
Other Name: Allogenic adipose-derived stem cell
Placebo Comparator: Placebo
Saline injection
 Drug: Placebo
Other Name: 0.9% Saline


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy [ Time Frame: Week 12 ]
    Improvement of VAS pain score at 12 weeks compared to baseline per each group


Secondary Outcome Measures :
  1. VAS pain score [ Time Frame: week 2, week 6 and week 12 ]
    Changes in the VAS pain score during activity per each group

  2. Improvement rate of VAS pain score [ Time Frame: week 2, week 6 and week 12 ]
    Improvement rate of VAS pain score at rest per each group

  3. Modified Mayo Clinic Performance Index [ Time Frame: week 2, week 6 and week 12 ]
    Change in Modified Mayo Clinic Performance Index per each group

  4. Ultrasonic photography [ Time Frame: week 6 and week 12 ]
    Change in analysis of lesion size per each group

  5. Safety [ Time Frame: Week 12 ]
    Clinically measured abnormality of laboratory tests and adverse events


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131077


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Chung-Ang University Hosptal
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Nanoori hospital
Seoul, Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
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Principal Investigator: S G Chung, M.D., Ph.D Seoul National University Hospital
More Information
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Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT02131077    
Other Study ID Numbers: ALLO-ASC-TI-201
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: May 2014
Keywords provided by Anterogen Co., Ltd.:
Lateral Epicondylitis
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries