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

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALLO-ASC-TI
Placebo
Sponsored by
Anterogen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral Epicondylitis

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center
  • Chung-Ang University Hosptal
  • Gangnam Severance Hospital
  • Nanoori hospital
  • Samsung medical center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment

Placebo

Arm Description

ALLO-ASC-TI injection

Saline injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS pain score
Changes in the VAS pain score during activity per each group
Improvement rate of VAS pain score
Improvement rate of VAS pain score at rest per each group
Modified Mayo Clinic Performance Index
Change in Modified Mayo Clinic Performance Index per each group
Ultrasonic photography
Change in analysis of lesion size per each group
Safety
Clinically measured abnormality of laboratory tests and adverse events

Full Information

First Posted
April 29, 2014
Last Updated
November 22, 2016
Sponsor
Anterogen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02131077
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterogen Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Lateral Epicondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
ALLO-ASC-TI injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline injection
Intervention Type
Biological
Intervention Name(s)
ALLO-ASC-TI
Other Intervention Name(s)
Allogenic adipose-derived stem cell
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Saline
Primary Outcome Measure Information:
Title
Efficacy
Description
Improvement of VAS pain score at 12 weeks compared to baseline per each group
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
VAS pain score
Description
Changes in the VAS pain score during activity per each group
Time Frame
week 2, week 6 and week 12
Title
Improvement rate of VAS pain score
Description
Improvement rate of VAS pain score at rest per each group
Time Frame
week 2, week 6 and week 12
Title
Modified Mayo Clinic Performance Index
Description
Change in Modified Mayo Clinic Performance Index per each group
Time Frame
week 2, week 6 and week 12
Title
Ultrasonic photography
Description
Change in analysis of lesion size per each group
Time Frame
week 6 and week 12
Title
Safety
Description
Clinically measured abnormality of laboratory tests and adverse events
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S G Chung, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hosptal
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Nanoori hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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