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

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

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.

Study Overview

• Status: Completed
• Conditions: Tennis Elbow
• Intervention / Treatment: Drug: Placebo; Biological: ALLO-ASC-TI

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Chung-Ang University Hosptal
  • Seoul, Korea, Republic of
    • Nanoori hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline injection	Drug: Placebo; Other Names: 0.9% Saline
Experimental: treatment; ALLO-ASC-TI injection	Biological: ALLO-ASC-TI; Other Names: Allogenic adipose-derived stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Improvement of VAS pain score at 12 weeks compared to baseline per each group	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score	Changes in the VAS pain score during activity per each group	week 2, week 6 and week 12
Improvement rate of VAS pain score	Improvement rate of VAS pain score at rest per each group	week 2, week 6 and week 12
Modified Mayo Clinic Performance Index	Change in Modified Mayo Clinic Performance Index per each group	week 2, week 6 and week 12
Ultrasonic photography	Change in analysis of lesion size per each group	week 6 and week 12
Safety	Clinically measured abnormality of laboratory tests and adverse events	Week 12

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: S G Chung, M.D., Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Lateral Epicondylitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: ALLO-ASC-TI-201