Lateral EpicondylitisEarly Phase 1ALLO-ASCNCT01856140

Treatment of Tendon Injury Using Mesenchymal Stem Cells

A Early Phase 1 study testing ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection 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

Search all trials

Trial summary

Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Lateral Epicondylitis
What is being tested?: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteSouth Korea
Study dates: May 2013to Apr 2018
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

clinically diagnosed as lateral epicondylitis (tennis elbow)
recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
symptom duration is over 6 months
defect in common extensor tendon can be observed under ultrasound
patient that can understand the clinical trials

Who cannot join

patient that underwent other injection treatment within 6 weeks
some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
patient that enrolled other clinical trials within 30 days
history of drug/alcohol addiction, habitual smoker

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University College of Medicine
Seoul

Other trials in South Korea

About this study

Official title: Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study

Read the detailed description

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).

The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.

Conditions: Lateral Epicondylitis
Being tested: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
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.

ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injectionBiological

Study groups in NCT01856140
Study group	Role	What they receive
1 million cells/ml of ALLO-ASC	Experimental	1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. Receives: Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
10 million cells/ml of ALLO-ASC	Active comparator	10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention. Receives: Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

What is being measured

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

Change From Baseline in Visual Analog Scale (VAS) at 6 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), higher scores meaning worse outcome.
Measured: Baseline, 6 weeks, 12 weeks after intervention

Secondary outcomes (3)

Modified Mayo Clinic Performance Index for the Elbow
The Modified Mayo clinic performance index for the elbow measures pain, motion, stability, and daily functions. (0 to 100) Higher score means better function.
Measured: Baseline, 6 weeks, 12 weeks after the intervention
Defect Area of Tendon by Ultrasonography in Long Axis
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the cephalic end of the ultrasound transducer was placed on the lateral epicondyle and the long axis of the transducer was aligned with the long axis of radius. The alignment of the transducer and radius was achieved by visualizing contours of the bony structures. Multiple cross-sectional images were saved by shifting the transducer medio-laterally by 2mm at a time. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Measured: Baseline, 6 weeks, and 12 weeks after the intervention
Defect Area of Tendon by Ultrasonography in Short Axis
Defect areas were measured as the largest defect of the common extensor tendon. Higher value means larger defect area.
With the patient supine position with the elbow in 30' flexion and full pronation, the transducer was placed on the proximal forearm just distal to the radial head, aligning the long axis of the transducer perpendicular to the long axis of the forearm. Viewing the round radius at the horizontal center, the transducer was shifted proximally by 2mm and multiple images were saved after the transducer passed the radial head until it slid over the prominence. Acquiring images were repeated three times.
Among the saved images, one image showing the largest defect were selected for every patients at every time points. Manual measurements of the defect area were conducted by tracking the perimeter using ImageJ 1.48 software (National Institutes of Health, http://imagej.nih.gov/ij/) and were repeated three times by two examiners in random orders and then, averaged.
Measured: Baseline, 6 weeks, and 12 weeks after the intervention

Timeline

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

May 2013Apr 2018

First posted17 May 2013 (estimated)
Study startMay 2013
Primary completionJul 2016
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01856140
Sponsor's protocol ID: SNUH-RM-SGChung-ASC-01
Acronym: ALLO-ASC
Status last verified: Feb 2022
First submitted: 26 Apr 2013
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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
Price R, Sinclair H, Heinrich I, Gibson T. Local injection treatment of tennis elbow--hydrocortisone, triamcinolone and lignocaine compared. Br J Rheumatol. 1991 Feb;30(1):39-44. doi: 10.1093/rheumatology/30.1.39.
PubMed 1991216
Sanchez M, Azofra J, Anitua E, Andia I, Padilla S, Santisteban J, Mujika I. Plasma rich in growth factors to treat an articular cartilage avulsion: a case report. Med Sci Sports Exerc. 2003 Oct;35(10):1648-52. doi: 10.1249/01.MSS.0000089344.44434.50.
PubMed 14523300
Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
PubMed 17910298
Solveborn SA, Buch F, Mallmin H, Adalberth G. Cortisone injection with anesthetic additives for radial epicondylalgia (tennis elbow). Clin Orthop Relat Res. 1995 Jul;(316):99-105.
PubMed 7634730
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
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
Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19.
PubMed 19380129
Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.
PubMed 17099241
Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995 Sep;13(5):655-63. doi: 10.1002/jor.1100130504.
PubMed 7472743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

All Lateral Epicondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study
ClinicalTrials.gov ID: NCT01856140
Acronym / sponsor ID: ALLO-ASC / SNUH-RM-SGChung-ASC-01
Conditions: Lateral Epicondylitis
Keywords: adipose derived mesenchymal stem cell, allogeneic stem cell
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Medical Research Collaborating Center, Seoul, Korea
Study start: May 2013 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Apr 2018 (actual)
First posted: 17 May 2013 (estimated)
Results: Posted 18 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1 million cells/ml of ALLO-ASC	Experimental	Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
10 million cells/ml of ALLO-ASC	Active comparator	Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

clinically diagnosed as lateral epicondylitis (tennis elbow)
recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
symptom duration is over 6 months
defect in common extensor tendon can be observed under ultrasound
patient that can understand the clinical trials

Key exclusion criteria (4 listed)

patient that underwent other injection treatment within 6 weeks
some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
patient that enrolled other clinical trials within 30 days
history of drug/alcohol addiction, habitual smoker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection	Biological	1 million cells/ml of ALLO-ASC, 10 million cells/ml of ALLO-ASC

Primary outcome

Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
Time frame: Baseline, 6 weeks, 12 weeks after intervention
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.

3 secondary outcomes

Modified Mayo Clinic Performance Index for the Elbow
Time frame: Baseline, 6 weeks, 12 weeks after the intervention
Defect Area of Tendon by Ultrasonography in Long Axis
Time frame: Baseline, 6 weeks, and 12 weeks after the intervention
Defect Area of Tendon by Ultrasonography in Short Axis
Time frame: Baseline, 6 weeks, and 12 weeks after the intervention

Results and safety

Results posted to the registry on 18 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Million Cells/ml of ALLO-ASC	6	6
10 Million Cells/ml of ALLO-ASC	6	6

Primary outcome: Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks

Time frame: Baseline, 6 weeks, 12 weeks after intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	1 Million Cells/ml of ALLO-ASC n = 6	10 Million Cells/ml of ALLO-ASC n = 6
Baseline	3.57 (2.1)	3.02 (1.34)
Post-injection 6 weeks	2.93 (3.06)	1.60 (1.80)
Post-injection 12 weeks	1.68 (1.90)	0.87 (0.67)

1 Million Cells/ml of ALLO-ASC vs 10 Million Cells/ml of ALLO-ASC: p = 0.52, Wilcoxon (Mann-Whitney)
1 Million Cells/ml of ALLO-ASC vs 10 Million Cells/ml of ALLO-ASC: p = 0.47, Wilcoxon (Mann-Whitney)
1 Million Cells/ml of ALLO-ASC vs 10 Million Cells/ml of ALLO-ASC: p = 0.52, Wilcoxon (Mann-Whitney)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Million Cells/ml of ALLO-ASC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
10 Million Cells/ml of ALLO-ASC	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20970844Coombes 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.
Background: PubMed 1991216Price R, Sinclair H, Heinrich I, Gibson T. Local injection treatment of tennis elbow--hydrocortisone, triamcinolone and lignocaine compared. Br J Rheumatol. 1991 Feb;30(1):39-44. doi: 10.1093/rheumatology/30.1.39.
Background: PubMed 14523300Sanchez M, Azofra J, Anitua E, Andia I, Padilla S, Santisteban J, Mujika I. Plasma rich in growth factors to treat an articular cartilage avulsion: a case report. Med Sci Sports Exerc. 2003 Oct;35(10):1648-52. doi: 10.1249/01.MSS.0000089344.44434.50.
Background: PubMed 17910298Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
Background: PubMed 7634730Solveborn SA, Buch F, Mallmin H, Adalberth G. Cortisone injection with anesthetic additives for radial epicondylalgia (tennis elbow). Clin Orthop Relat Res. 1995 Jul;(316):99-105.
Background: PubMed 21048180Maffulli 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.
Background: PubMed 16735582Mishra 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.
Background: PubMed 19380129Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19.
Background: PubMed 17099241Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.
Background: PubMed 7472743Slater M, Patava J, Kingham K, Mason RS. Involvement of platelets in stimulating osteogenic activity. J Orthop Res. 1995 Sep;13(5):655-63. doi: 10.1002/jor.1100130504.

Related trials for Lateral Epicondylitis

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sun Gun Chung, MD, PhD principal investigator

Seoul National University College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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 18 Mar 2022. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks (time frame: Baseline, 6 weeks, 12 weeks after intervention). 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 NCT01856140, which also lists 10 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 18 Mar 2022.