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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Sun Gun Chung, Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01856140
First Posted: May 17, 2013
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Sun Gun Chung, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: April 26, 2013
First Posted: May 17, 2013
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Sun Gun Chung, Seoul National University Hospital:
adipose derived mesenchymal stem cell
allogeneic stem cell

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