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
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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 |
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
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Study Start Date : | May 4, 2018 |
Actual Primary Completion Date : | April 3, 2019 |
Estimated Study Completion Date : | December 30, 2021 |
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
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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 |
- 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).
- 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.

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

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
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Sun Gun Chung, MD, PhD | Seoul National University Hospital |
Responsible Party: | Sun Gun Chung, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT03449082 |
Other Study ID Numbers: |
SNUH-RM-SGChung-ASC-02 |
First Posted: | February 28, 2018 Key Record Dates |
Last Update Posted: | March 26, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
adipose derived mesenchymal stem cell allogeneic stem cell |
Tennis Elbow Tendon Injuries Elbow Tendinopathy Tendinopathy Muscular Diseases Musculoskeletal Diseases |
Arm Injuries Wounds and Injuries Fibrin Tissue Adhesive Hemostatics Coagulants |