Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)

NCT02298023 | Completed Phase 2 Results

• 1 other identifier: ALLO-ASC_TR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear by ultrasonographic guided injection.

Conditions

Rotator Cuff Tear

Keywords

adipose derived mesenchymal stem cell; allogeneic stem cell; Rotator cuff tear

Outcome Measures

Primary Outcomes (1)

• Change of Pain During Activity From Baseline to 3 Months After Intervention

  Pain during activity will be evaluated by visual analog scale (active pain VAS). The active pain visual analog scale change from baseline to 3 months after intervention is the primary outcome. Visual analog scale is scored 0 to 10, higher scored meaning worse outcome. Negative values in change of pain during activity indicate improvement in pain.

  Baseline and 3 months after intervention

Secondary Outcomes (7)

• Pain During Rest

  Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

• Pain During Activity

  Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

• Disability of Arm, Shoulder and Hand (DASH) Score

  Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

• University of California, Los Angeles(UCLA) Shoulder Score

  Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention

Study Arms (3)

Mesenchymal stem cell group

EXPERIMENTAL

Received allogenic adipose tissue-derived adult mesenchymal stem cells (10million cells) in fibrin glue scaffold.

Biological: allogenic adipose stem cell injection

Active control (fibrin glue) group

ACTIVE COMPARATOR

Received fibrin glue and normal saline.

Biological: fibrin glue/normal saline injection

Control (normal saline )group

PLACEBO COMPARATOR

Received only normal saline.

Biological: normal saline injection

Interventions

allogenic adipose stem cell injection BIOLOGICAL

Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.

Also known as: experimental group

Mesenchymal stem cell group

fibrin glue/normal saline injection BIOLOGICAL

Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise

Also known as: active control group

Active control (fibrin glue) group

normal saline injection BIOLOGICAL

Total 1cc of normal saline injection and range of motion exercise

Also known as: placebo group

Control (normal saline )group

Eligibility Criteria

• Age: 19 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 (supraspinatus partial thickness tear)
• recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
• symptom duration is over 3 months
• supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
• patient that can understand the clinical trials

You may not qualify if:

• patient that underwent other injection treatment within 6 weeks
• some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
• patient that enrolled other clinical trials within 30 days
• history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University College of Medicine

Seoul, South Korea

Location

Related Publications (42)

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MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Sun G. Chung
• Organization: , Seoul National University Hospital

chung60611@gmail.com

+82-2-2072-2560

Study Officials

• Sun Gun Chung, MD, PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: September 1, 2014
• Primary Completion: July 19, 2016
• Study Completion: April 10, 2018
• Last Updated: October 19, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-09

Locations

KR (1)