Treatment of Tendon Injury Using Mesenchymal Stem Cells (ALLO-ASC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01856140
First received: April 26, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.


Condition Intervention Phase
Lateral Epicondylitis
Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change from baseline in Visual analog scale (VAS) at 6 and 12 weeks [ Time Frame: Baseline, 6 weeks, 12 weeks after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: May 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 million cells/ml of ALLO-ASC
1 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Active Comparator: 10 million cells/ml of ALLO-ASC
10 million cells/ml of ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) will be injected by ultrasound guided intervention.
Biological: ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection

Detailed Description:

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).

The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically diagnosed as lateral epicondylitis (tennis elbow)
  • recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
  • symptom duration is over 6 months
  • defect in common extensor tendon can be observed under ultrasound
  • patient that can understand the clinical trials

Exclusion Criteria:

  • 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 30 days
  • history of drug/alcohol addiction, habitual smoker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856140

Contacts
Contact: Sun Gun Chung, MD, PhD +82-2-2072-3954 suncg@snu.ac.kr
Contact: Sang Yoon Lee, MD, MS +82-2-2072-2967 rehabilee@gmail.com

Locations
Korea, Republic of
Seoul National University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Sun Gun Chung, MD, PhD    +82-2-2072-3954    suncg@snu.ac.kr   
Principal Investigator: Sun Gun Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sun Gun Chung, MD, PhD Seoul National University College of Medicine
  More Information

Publications:

Responsible Party: Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01856140     History of Changes
Other Study ID Numbers: SNUH-RM-SGChung-ASC-01
Study First Received: April 26, 2013
Last Updated: November 22, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
adipose derived mesenchymal stem cell
allogeneic stem cell

Additional relevant MeSH terms:
Tendon Injuries
Tennis Elbow
Arm Injuries
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014