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Rotator Cuff TearPhase 2NCT03279796

Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells

A Phase 2 study testing Autologous adipose-derived MSCs and Compound betamethasone in people with Rotator Cuff Tear and Lateral Epicondylitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rotator Cuff Tear, Lateral Epicondylitis
What is being tested?
Autologous adipose-derived MSCs and Compound betamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Oct 2018to 31 Dec 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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow);
  • symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
  • patient that can understand the clinical trials and signed the informed consent.

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 3 months
  • history of drug/alcohol addiction, habitual smoker

Trial locations and contacts

1 site in 1 country.

Weiliang Shen, Doctor contact

+86-13757101563

wlshen@zju.edu.cn

China1 site

  • Weiliang Shen

    Hangzhou, Zhejiang, 310058

    Weiliang Shen, Doctor

Other trials in China

About this study

Official title: Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial

This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

Read the detailed description

All injection will be done under ultrasound guidance.

Being tested
Autologous adipose-derived MSCs, Compound betamethasone
Keywords
Adipose-drived mesenchymal stem cells, Rotator cuff injury, Lateral Epicondylitis, Randomized controlled trials
Medical subject headings
Rotator Cuff Injuries, Tennis Elbow

What participants receive

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

  • Autologous adipose-derived MSCsBiological

    The dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times.

  • Compound betamethasoneDrug

    1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times.

Study groups in NCT03279796
Study groupRoleWhat they receive
Autologous adipose-derived MSCsExperimentalThe dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times.
Receives: Biological: Autologous adipose-derived MSCs
Compound betamethasoneActive comparator1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times.
Receives: Drug: Compound betamethasone

What is being measured

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

  1. Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks

    Pain on activity will be evaluated by VAS

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

Secondary outcomes (4)

  1. Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks,

    Functional score of the shoulder

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

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

    Functional score of the shoulder

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

  3. The Disabilities of the Arm, Shoulder and Hand(DASH) Score

    Functional score of the shoulder

    Measured: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

  4. Adverse events

    Adverse events to evaluate the safety

    Measured: From baseline through study completion, an average of 1 year

Timeline

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

  1. First posted12 Sep 2017
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2021 (estimated)

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
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279796
Sponsor's protocol ID
2017.No.55
Status last verified
Aug 2017
First submitted
4 Sep 2017
Last updated
26 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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

  • Pas HIMFL, Moen MH, Haisma HJ, Winters M. No evidence for the use of stem cell therapy for tendon disorders: a systematic review. Br J Sports Med. 2017 Jul;51(13):996-1002. doi: 10.1136/bjsports-2016-096794. Epub 2017 Jan 11.

    PubMed 28077355

  • 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

  • Ouyang HW, Goh JC, Thambyah A, Teoh SH, Lee EH. Knitted poly-lactide-co-glycolide scaffold loaded with bone marrow stromal cells in repair and regeneration of rabbit Achilles tendon. Tissue Eng. 2003 Jun;9(3):431-9. doi: 10.1089/107632703322066615.

    PubMed 12857411

  • Minagawa H, Yamamoto N, Abe H, Fukuda M, Seki N, Kikuchi K, Kijima H, Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village. J Orthop. 2013 Feb 26;10(1):8-12. doi: 10.1016/j.jor.2013.01.008. eCollection 2013.

    PubMed 24403741

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous adipose-derived MSCs and Compound betamethasone in people with Rotator Cuff Tear and Lateral Epicondylitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 3 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. 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 China. 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?

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?

Results are not available in the source record.

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

Contact Weiliang Shen, Doctor (+86-13757101563, wlshen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks (time frame: Baseline, 3 weeks, 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 NCT03279796, which also lists 7 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 26 Apr 2018.

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