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Completed

NCT Number: NCT02131077

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

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.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALLO-ASC-TI

Biological

Other names: Allogenic adipose-derived stem cell

Placebo

Drug

Other names: 0.9% Saline

Primary outcomes

  1. Efficacy

    Time frame: Week 12

    Improvement of VAS pain score at 12 weeks compared to baseline per each group

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 6, 2014
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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