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

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ClinicalTrials.gov Identifier: NCT03279796
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Zhejiang Xingyue Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Lateral Epicondylitis Biological: Autologous adipose-derived MSCs Drug: Compound betamethasone Phase 2

Detailed Description:
All injection will be done under ultrasound guidance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention ]
    Functional score of the shoulder

  3. 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

  4. Adverse events [ Time Frame: From baseline through study completion, an average of 1 year ]
    Adverse events to evaluate the safety



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279796


Contacts
Contact: Weiliang Shen, Doctor +86-13757101563 wlshen@zju.edu.cn

Locations
China, Zhejiang
Weiliang Shen Not yet recruiting
Hangzhou, Zhejiang, China, 310058
Contact: Weiliang Shen, Doctor         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Xingyue Biotechnology Co., Ltd.

Publications:

Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03279796     History of Changes
Other Study ID Numbers: 2017.No.55
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Adipose-drived mesenchymal stem cells
Rotator cuff injury
Lateral Epicondylitis
Randomized controlled trials

Additional relevant MeSH terms:
Tennis Elbow
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents