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Rotator Cuff TearPhase 2NCT02298023

Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)

A Phase 2 study testing allogenic adipose stem cell injection, fibrin glue/normal saline injection and normal saline injection in people with Rotator Cuff Tear, 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

Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear by ultrasonographic guided injection. Read more about this study

Who is it for?
Ages 19 to 90 years
Conditions the study is for
Rotator Cuff Tear
What is being tested?
allogenic adipose stem cell injection, fibrin glue/normal saline injection and normal saline injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteSouth Korea
Study dates
Sep 2014to 10 Apr 2018
Phase
Phase 2
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 rotator cuff tear (supraspinatus partial thickness tear)
  • recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
  • symptom duration is over 3 months
  • supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
  • patient that can understand the clinical trials

Who cannot join

  • patient that underwent other injection treatment within 6 weeks
  • some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
  • patient that enrolled other clinical trials within 30 days
  • history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.

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: Phase II Double-Blind Placebo-Controlled Randomized Clinical Trials.

Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear by ultrasonographic guided injection.

Read the detailed description

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. Double blind Randomized placebo controlled study will be done with following 3 groups. Each group will have 8 people, so, the total patients will be 24 people.

  1. Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc + range of motion exercise
  2. Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of motion exercise
  3. Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of motion exercise

The investigators will compare the efficacy difference with VAS(visual analog scale, primary outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California, Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and change of tear size compared to the baseline image assessed by MRI. These measurement will be done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6 months, 12months and 24 months except for the evaluation of the tear size which will be done at baseline, 3 months and 24 months after the intervention.

Being tested
allogenic adipose stem cell injection, fibrin glue/normal saline injection, normal saline injection
Keywords
adipose derived mesenchymal stem cell, allogeneic stem cell, Rotator cuff tear
Medical subject headings
Rotator Cuff Injuries

What participants receive

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

  • allogenic adipose stem cell injectionBiological

    Also called experimental group

    Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.

  • fibrin glue/normal saline injectionBiological

    Also called active control group

    Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise

  • normal saline injectionBiological

    Also called placebo group

    Total 1cc of normal saline injection and range of motion exercise

Study groups in NCT02298023
Study groupRoleWhat they receive
Mesenchymal stem cell groupExperimentalReceived allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.
Receives: Biological: allogenic adipose stem cell injection
Active control (fibrin glue) groupActive comparatorReceived fibrin glue and normal saline.
Receives: Biological: fibrin glue/normal saline injection
Control (normal saline )groupPlacebo comparatorReceived only normal saline.
Receives: Biological: normal saline injection

What is being measured

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

  1. Change of Pain During Activity From Baseline to 3 Months After Intervention

    Pain during activity will be evaluated by visual analog scale (active pain VAS). The active pain visual analog scale change from baseline to 3 months after intervention is the primary outcome. Visual analog scale is scored 0 to 10, higher scored meaning worse outcome. Negative values in change of pain during activity indicate improvement in pain.

    Measured: Baseline and 3 months after intervention

Secondary outcomes (7)

  1. Pain During Rest

    Pain during rest assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome.

    Measured: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

  2. Pain During Activity

    Pain during activity assessed by visual analog scale (VAS), scored 0 to 10, higher scores meaning worse outcome

    Measured: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

  3. American Shoulder and Elbow Surgeons (ASES) Shoulder Score

    Functional score of the shoulder was assessed by American Shoulder and Elbow Surgeons shoulder score which is a questionnaire dedicated to the functional evaluation of the shoulder. It is scored from 0 to 100, higher scores meaning better outcome.

    Measured: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

  4. Disability of Arm, Shoulder and Hand (DASH) Score

    Shoulder function is assessed by DASH score which is questionnaire dedicated to evaluate the function of the upper extremity. It is scored from 0 (no disability) to 100 (most severe disability).

    Measured: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

  5. University of California, Los Angeles(UCLA) Shoulder Score

    Shoulder function is assessed by UCLA shoulder score which is a composite of range of motion examination and questionnaire dedicated to evaluate the function of the shoulder. It is scored from 0 to 35, higher scores meaning better shoulder function.

    Measured: Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

  6. Tear Size at 3 Months After Injection

    Tear size was evaluated by 3-point Likert scale using MRI. The 3months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.

    Measured: baseline and 3 months after intervention

  7. Tear Size at 12 Months After Injection

    Tear size was evaluated by 3-point Likert scale using MRI. The 12 months follow-up images were compared to the baseline image and graded either; improved, stationary, and aggravated.

    Measured: baseline and12 months after intervention

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion19 Jul 2016
  4. Study completion10 Apr 2018

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298023
Sponsor's protocol ID
ALLO-ASC_TR
Status last verified
Sep 2021
First submitted
19 Nov 2014
Last updated
19 Oct 2021
Data monitoring committee
No

Publications

  • Isaac C, Gharaibeh B, Witt M, Wright VJ, Huard J. Biologic approaches to enhance rotator cuff healing after injury. J Shoulder Elbow Surg. 2012 Feb;21(2):181-90. doi: 10.1016/j.jse.2011.10.004.

    PubMed 22244061

  • 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

  • Tashjian RZ. Epidemiology, natural history, and indications for treatment of rotator cuff tears. Clin Sports Med. 2012 Oct;31(4):589-604. doi: 10.1016/j.csm.2012.07.001. Epub 2012 Aug 30.

    PubMed 23040548

  • 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

  • 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

  • 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

  • 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

  • Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.

    PubMed 17910298

  • 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

  • Arce G, Bak K, Bain G, Calvo E, Ejnisman B, Di Giacomo G, Gutierrez V, Guttmann D, Itoi E, Ben Kibler W, Ludvigsen T, Mazzocca A, de Castro Pochini A, Savoie F 3rd, Sugaya H, Uribe J, Vergara F, Willems J, Yoo YS, McNeil JW 2nd, Provencher MT. Management of disorders of the rotator cuff: proceedings of the ISAKOS upper extremity committee consensus meeting. Arthroscopy. 2013 Nov;29(11):1840-50. doi: 10.1016/j.arthro.2013.07.265. Epub 2013 Sep 13.

    PubMed 24041864

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing allogenic adipose stem cell injection, fibrin glue/normal saline injection and normal saline injection in people with Rotator Cuff Tear, 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 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 19 Oct 2021. 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?

Yes. Results are posted in the registry (first posted 30 Jun 2021). 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 of Pain During Activity From Baseline to 3 Months After Intervention (time frame: Baseline and 3 months 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 NCT02298023, which also lists 42 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 19 Oct 2021.

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