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

April 24, 2018 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All injection will be done under ultrasound guidance.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • Weiliang Shen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pain on activity will be evaluated by VAS
Baseline, 3 weeks, 6 weeks, 12 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks,
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Functional score of the shoulder
Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Functional score of the shoulder
Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
The Disabilities of the Arm, Shoulder and Hand(DASH) Score
Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Functional score of the shoulder
Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Adverse events
Time Frame: From baseline through study completion, an average of 1 year
Adverse events to evaluate the safety
From baseline through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Zhejiang Xingyue Biotechnology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 10, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017.No.55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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