NCT02131077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 23, 2016

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

April 29, 2014

Last Update Submit

November 22, 2016

Conditions

Tennis Elbow

Keywords

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

  • Efficacy

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

    Week 12

Secondary Outcomes (5)

  • VAS pain score

    week 2, week 6 and week 12

  • Improvement rate of VAS pain score

    week 2, week 6 and week 12

  • Modified Mayo Clinic Performance Index

    week 2, week 6 and week 12

  • Ultrasonic photography

    week 6 and week 12

  • Safety

    Week 12

Study Arms (2)

treatment

EXPERIMENTAL

ALLO-ASC-TI injection

Biological: ALLO-ASC-TI

Placebo

PLACEBO COMPARATOR

Saline injection

Drug: Placebo

Interventions

ALLO-ASC-TIBIOLOGICAL
Also known as: Allogenic adipose-derived stem cell
treatment
PlaceboDRUG
Also known as: 0.9% Saline
Placebo

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Hosptal

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Nanoori hospital

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • S G Chung, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 6, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

August 1, 2015

Last Updated

November 23, 2016

Record last verified: 2014-05

Locations

KR(6)