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Lateral EpicondylitisPhase 2NCT03449082

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

A Phase 2 study testing High concentration of Allo-ASC, Low concentration of Allo-ASC and Fibrin glue in people with Lateral Epicondylitis, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Lateral Epicondylitis
What is being tested?
High concentration of Allo-ASC, Low concentration of Allo-ASC and Fibrin glue
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSouth Korea
Study dates
15 Mar 2018to 8 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial

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.

Read the 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
Being tested
High concentration of Allo-ASC, Low concentration of Allo-ASC, Fibrin glue, Normal saline
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High concentration of Allo-ASCBiological

    10 million cells of Allo-ASC 0.5cc

  • Low concentration of Allo-ASCBiological

    1 million cells of Allo-ASC 0.5cc

  • Fibrin glueDrug

    Also called Fibrin sealant

    Fibrin glue 0.5cc

  • Normal salineDrug

    Also called 0.9% Sodium Chloride Solution

    Normal saline 0.5cc

Study groups in NCT03449082
Study groupRoleWhat they receive
High concentration of Allo-ASC groupExperimentalHigh concentration of Allo-ASC 0.5cc (Total: 10 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Receives: Biological: High concentration of Allo-ASC; Drug: Fibrin glue
Low concentration of Allo-ASC groupExperimentalLow concentration of Allo-ASC 0.5cc (Total: 1 million cells) \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Receives: Biological: Low concentration of Allo-ASC; Drug: Fibrin glue
Placebo Comparator (Fibrin) groupPlacebo comparatorNormal saline 0.5cc \& Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
Receives: Drug: Fibrin glue; Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline and 12 weeks

Secondary outcomes (6)

  1. 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).

    Measured: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

  2. 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).

    Measured: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

  3. Change of Mayo elbow performance index (MEPI)

    The MEPI measures pain, motion, stability, and daily functions. (0 = worst, 100 = best)

    Measured: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

  4. 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.

    Measured: baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months

  5. Shear wave elastography

    Young modulus and shear wave speed will be obtained

    Measured: baseline, 12 weeks and 24 months

  6. 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.

    Measured: baseline, 12 weeks and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start15 Mar 2018
  3. Primary completion16 Jul 2019
  4. Study completion8 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449082
Sponsor's protocol ID
SNUH-RM-SGChung-ASC-02
Status last verified
Apr 2025
First submitted
30 Jan 2018
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells. 2015 Oct;33(10):2995-3005. doi: 10.1002/stem.2110. Epub 2015 Aug 6.

    PubMed 26202898

  • Lee SY, Kwon B, Lee K, Son YH, Chung SG. Therapeutic Mechanisms of Human Adipose-Derived Mesenchymal Stem Cells in a Rat Tendon Injury Model. Am J Sports Med. 2017 May;45(6):1429-1439. doi: 10.1177/0363546517689874. Epub 2017 Mar 14.

    PubMed 28291954

  • Pascual-Garrido C, Rolon A, Makino A. Treatment of chronic patellar tendinopathy with autologous bone marrow stem cells: a 5-year-followup. Stem Cells Int. 2012;2012:953510. doi: 10.1155/2012/953510. Epub 2011 Dec 18.

    PubMed 22220180

  • Ellera Gomes JL, da Silva RC, Silla LM, Abreu MR, Pellanda R. Conventional rotator cuff repair complemented by the aid of mononuclear autologous stem cells. Knee Surg Sports Traumatol Arthrosc. 2012 Feb;20(2):373-7. doi: 10.1007/s00167-011-1607-9. Epub 2011 Jul 20.

    PubMed 21773831

  • Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.

    PubMed 24913770

  • Zhang X, Lin YC, Rui YF, Xu HL, Chen H, Wang C, Teng GJ. Therapeutic Roles of Tendon Stem/Progenitor Cells in Tendinopathy. Stem Cells Int. 2016;2016:4076578. doi: 10.1155/2016/4076578. Epub 2016 Apr 19.

    PubMed 27195010

  • Clarke AW, Alyas F, Morris T, Robertson CJ, Bell J, Connell DA. Skin-derived tenocyte-like cells for the treatment of patellar tendinopathy. Am J Sports Med. 2011 Mar;39(3):614-23. doi: 10.1177/0363546510387095. Epub 2010 Dec 7.

    PubMed 21139155

  • Leong DJ, Sun HB. Mesenchymal stem cells in tendon repair and regeneration: basic understanding and translational challenges. Ann N Y Acad Sci. 2016 Nov;1383(1):88-96. doi: 10.1111/nyas.13262. Epub 2016 Oct 5.

    PubMed 27706825

  • Muller SA, Todorov A, Heisterbach PE, Martin I, Majewski M. Tendon healing: an overview of physiology, biology, and pathology of tendon healing and systematic review of state of the art in tendon bioengineering. Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2097-105. doi: 10.1007/s00167-013-2680-z. Epub 2013 Sep 21.

    PubMed 24057354

  • Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.

    PubMed 20970844

  • Maffulli N, Longo UG, Denaro V. Novel approaches for the management of tendinopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2604-13. doi: 10.2106/JBJS.I.01744.

    PubMed 21048180

  • Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.

    PubMed 20448192

  • Tobita M, Orbay H, Mizuno H. Adipose-derived stem cells: current findings and future perspectives. Discov Med. 2011 Feb;11(57):160-70.

    PubMed 21356171

  • Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.

    PubMed 16735582

  • Chong AK, Ang AD, Goh JC, Hui JH, Lim AY, Lee EH, Lim BH. Bone marrow-derived mesenchymal stem cells influence early tendon-healing in a rabbit achilles tendon model. J Bone Joint Surg Am. 2007 Jan;89(1):74-81. doi: 10.2106/JBJS.E.01396.

    PubMed 17200313

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High concentration of Allo-ASC, Low concentration of Allo-ASC and Fibrin glue in people with Lateral Epicondylitis, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of pain visual analogue scale (VAS) during activity (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03449082, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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