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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03279796
• Other study ID #: 2017.No.55
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 4, 2017
• Last updated: April 24, 2018
• Start date: October 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Weiliang Shen, Doctor
• Phone: +86-13757101563
• Email: wlshen[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

All injection will be done under ultrasound guidance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow);

2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;

3. patient that can understand the clinical trials and signed the informed consent.

Exclusion Criteria:

1. patient that underwent other injection treatment within 6 weeks

2. 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)

3. patient that enrolled other clinical trials within 3 months

4. history of drug/alcohol addiction, habitual smoker

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Tennis Elbow

Intervention

Biological:
• Autologous adipose-derived MSCs
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.

Drug:
• Compound betamethasone
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.

Locations

Country	Name	City	State
China	Weiliang Shen	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Zhejiang Xingyue Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Pascual-Garrido C, Rolón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks	Pain on activity will be evaluated by VAS	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks,	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	The Disabilities of the Arm, Shoulder and Hand(DASH) Score	Functional score of the shoulder	Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Secondary	Adverse events	Adverse events to evaluate the safety	From baseline through study completion, an average of 1 year