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Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)

Primary Purpose

Lateral Epicondylitis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High concentration of Allo-ASC
Low concentration of Allo-ASC
Fibrin glue
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring adipose derived mesenchymal stem cell, allogeneic stem cell

Eligibility Criteria

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

Inclusion Criteria:

  • clinically diagnosed as lateral epicondylosis (tennis elbow)
  • symptom duration is over 12 months
  • pain visual analogue scale (VAS) during activity ≥ 5
  • recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
  • common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)
  • patient that can understand the clinical trials

Exclusion Criteria:

  • patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks
  • patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)
  • patient that enrolled other clinical trials within 30 days
  • current pregnancy or breast-feeding, planning for pregnancy
  • history of drug/alcohol addiction, habitual smoker
  • operation history of affected elbow
  • previous clinical trial involving stem cell administration
  • other severe medical illness or bleeding tendency
  • size of intramural calcification over 2.0 mm under ultrasound evaluation

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High concentration of Allo-ASC group

Low concentration of Allo-ASC group

Placebo Comparator (Fibrin) group

Arm Description

High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection

Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection

Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection

Outcomes

Primary Outcome Measures

Change of pain visual analogue scale (VAS) during activity
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).

Secondary Outcome Measures

Change of pain visual analogue scale (VAS) during activity
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Change of pain visual analogue scale (VAS) at rest
Self reported pain intensity at rest will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Change of Mayo elbow performance index (MEPI)
The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)
Ultrasonographic assessment
Ultrasonographic findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). Sonographic images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.
Shear wave elastography
Young modulus and shear wave speed will be obtained
Magnetic resonance image (MRI) assessment
MRI findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). MR images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.

Full Information

First Posted
January 30, 2018
Last Updated
March 25, 2021
Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03449082
Brief Title
Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)
Official Title
Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patients in comparison with a control treatment.
Detailed Description
A phase II randomized placebo controlled trial will be done with following 3 groups. Each group will have 10 participants, so, the total patients will be 30 people. High concentration of Allo-ASC group: stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc Low concentration of Allo-ASC group: stem cell 0.5cc (Total: 1 million cells) + Fibrin glue 0.5cc Placebo Comparator (Fibrin) group: Normal saline 0.5cc + Fibrin glue 0.5cc The investigators will compare the efficacy difference with visual analogue scale (VAS) during activity (primary outcome), VAS at rest, Mayo elbow performance index (MEPI), grip strength, ultrasonographic assessment at baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months after injection. Shear wave elastography (SWE) and magnetic resonance image (MRI) will be done at baseline, 12 weeks, 12 months and 24 months after injection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High concentration of Allo-ASC group
Arm Type
Experimental
Arm Description
High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Arm Title
Low concentration of Allo-ASC group
Arm Type
Experimental
Arm Description
Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Arm Title
Placebo Comparator (Fibrin) group
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Intervention Type
Biological
Intervention Name(s)
High concentration of Allo-ASC
Intervention Description
10 million cells of Allo-ASC 0.5cc
Intervention Type
Biological
Intervention Name(s)
Low concentration of Allo-ASC
Intervention Description
1 million cells of Allo-ASC 0.5cc
Intervention Type
Drug
Intervention Name(s)
Fibrin glue
Other Intervention Name(s)
Fibrin sealant
Intervention Description
Fibrin glue 0.5cc
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% Sodium Chloride Solution
Intervention Description
Normal saline 0.5cc
Primary Outcome Measure Information:
Title
Change of pain visual analogue scale (VAS) during activity
Description
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change of pain visual analogue scale (VAS) during activity
Description
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time Frame
baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Title
Change of pain visual analogue scale (VAS) at rest
Description
Self reported pain intensity at rest will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Time Frame
baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Title
Change of Mayo elbow performance index (MEPI)
Description
The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)
Time Frame
baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Title
Ultrasonographic assessment
Description
Ultrasonographic findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). Sonographic images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.
Time Frame
baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months
Title
Shear wave elastography
Description
Young modulus and shear wave speed will be obtained
Time Frame
baseline, 12 weeks and 24 months
Title
Magnetic resonance image (MRI) assessment
Description
MRI findings will be analyzed using a 5-point Likert scale (1: more aggravated, 2: aggravated, 3: same, 4: improved, 5: more improved). MR images will be compared with baseline images by experienced ultrasound examiners being blind to the treatment group and the time points of image achievement.
Time Frame
baseline, 12 weeks and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinically diagnosed as lateral epicondylosis (tennis elbow) symptom duration is over 12 months pain visual analogue scale (VAS) during activity ≥ 5 recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity) patient that can understand the clinical trials Exclusion Criteria: patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI) patient that enrolled other clinical trials within 30 days current pregnancy or breast-feeding, planning for pregnancy history of drug/alcohol addiction, habitual smoker operation history of affected elbow previous clinical trial involving stem cell administration other severe medical illness or bleeding tendency size of intramural calcification over 2.0 mm under ultrasound evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Gun Chung, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)

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