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

NCT03279796 | Unknown Phase 2

• 1 other identifier: 2017.No.55
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tear; Lateral Epicondylitis

Keywords

Adipose-drived mesenchymal stem cells; Rotator cuff injury; Lateral Epicondylitis; Randomized controlled trials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

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

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

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

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

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

• Adverse events

  From baseline through study completion, an average of 1 year

Study Arms (2)

Autologous adipose-derived MSCs

EXPERIMENTAL

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.

Biological: Autologous adipose-derived MSCs

Compound betamethasone

ACTIVE COMPARATOR

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.

Drug: Compound betamethasone

Interventions

Autologous adipose-derived MSCs BIOLOGICAL

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.

Autologous adipose-derived MSCs

Compound betamethasone DRUG

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.

Compound betamethasone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Xingyue Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Weiliang Shen

Hangzhou, Zhejiang, 310058, China

Location

Related 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.

  PMID: 21773831 BACKGROUND

• 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.

  PMID: 22220180 BACKGROUND

• 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.

  PMID: 24913770 BACKGROUND

• 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.

  PMID: 28077355 BACKGROUND

• 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.

  PMID: 26202898 BACKGROUND

• 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.

  PMID: 12857411 BACKGROUND

• 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.

  PMID: 24403741 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Tennis Elbow

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries

Central Study Contacts

Weiliang Shen, Doctor

CONTACT

+86-13757101563; wlshen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 12, 2017
• Study Start: October 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: April 26, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)