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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 : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Biological: High concentration of Allo-ASC Biological: Low concentration of Allo-ASC Drug: Fibrin glue Drug: Normal saline Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial
Estimated Study Start Date : March 10, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
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
Biological: High concentration of Allo-ASC
10 million cells of Allo-ASC 0.5cc

Drug: Fibrin glue
Fibrin glue 0.5cc
Other Name: Fibrin sealant

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
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

Placebo Comparator: Placebo Comparator (Fibrin) group
Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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)

  4. 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.

  5. Shear wave elastography [ Time Frame: baseline, 12 weeks and 24 months ]
    Young modulus and shear wave speed will be obtained

  6. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449082


Contacts
Contact: Sun Gun Chung, MD, PhD +82-2-2072-2560 suncg@snu.ac.kr
Contact: Jae Hyeon Park, MD +82-2-2072-3401 cupiote@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sun Gun Chung, MD, PhD    +82-2-2072-3954    suncg@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Korea Health Industry Development Institute
Investigators
Principal Investigator: Sun Gun Chung, MD, PhD Seoul National University Hospital

Publications:

Responsible Party: Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03449082     History of Changes
Other Study ID Numbers: SNUH-RM-SGChung-ASC-02
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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

Keywords provided by Sun Gun Chung, Seoul National University Hospital:
adipose derived mesenchymal stem cell
allogeneic stem cell

Additional relevant MeSH terms:
Tennis Elbow
Tendon Injuries
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Allopurinol
Fibrin Tissue Adhesive
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Hemostatics
Coagulants