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

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ClinicalTrials.gov Identifier: NCT03449082
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE May 4, 2018
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Change of pain visual analogue scale (VAS) during activity [ Time Frame: baseline and 12 weeks ]
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • Change of pain visual analogue scale (VAS) during activity [ Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months ]
    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 [ Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months ]
    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) [ Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months ]
    The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)
  • Ultrasonographic assessment [ Time Frame: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months ]
    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 [ Time Frame: baseline, 12 weeks and 24 months ]
    Young modulus and shear wave speed will be obtained
  • Magnetic resonance image (MRI) assessment [ Time Frame: baseline, 12 weeks and 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Intractable Common Extensor Tendon Injury Using Mesenchymal Stem Cells (Allo-ASC)
Official Title  ICMJE Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial
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.

  1. High concentration of Allo-ASC group: stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc
  2. Low concentration of Allo-ASC group: stem cell 0.5cc (Total: 1 million cells) + Fibrin glue 0.5cc
  3. 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lateral Epicondylitis
Intervention  ICMJE
  • Biological: High concentration of Allo-ASC
    10 million cells of Allo-ASC 0.5cc
  • Biological: Low concentration of Allo-ASC
    1 million cells of Allo-ASC 0.5cc
  • Drug: Fibrin glue
    Fibrin glue 0.5cc
    Other Name: Fibrin sealant
  • Drug: Normal saline
    Normal saline 0.5cc
    Other Name: 0.9% Sodium Chloride Solution
Study Arms  ICMJE
  • Experimental: High concentration of Allo-ASC group
    High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
    Interventions:
    • Biological: High concentration of Allo-ASC
    • Drug: Fibrin glue
  • Experimental: Low concentration of Allo-ASC group
    Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
    Interventions:
    • Biological: Low concentration of Allo-ASC
    • Drug: Fibrin glue
  • Placebo Comparator: Placebo Comparator (Fibrin) group
    Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
    Interventions:
    • Drug: Fibrin glue
    • Drug: Normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03449082
Other Study ID Numbers  ICMJE SNUH-RM-SGChung-ASC-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun Gun Chung, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Korea Health Industry Development Institute
Investigators  ICMJE
Principal Investigator: Sun Gun Chung, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP