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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT01300598
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
R-Bio

Study Description
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Brief Summary:
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with degenerative arthritis.

Condition or disease Intervention/treatment Phase
Degenerative Arthritis Procedure: Autologous Adipose Tissue derived MSCs Transplantation Phase 1 Phase 2

Detailed Description:

degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.

Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.

Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need.

The availability of large quantities of MSCs and their potential for ready chondrogenic differentiation after prolonged in vitro expansion have made MSCs the most hopeful candidate progenitor cell source for cartilage tissue engineering.

In the clinical study, mesenchymal stem cells will be isolated from adipose tissue and cultured, and administered into the cartilage tissue lesion by orthopedic surgery.

It will be stimulate the regeneration of defective cartilage tissue and to improve their functions.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Study Start Date : December 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
    Other Name: RNL-JointStem®

Outcome Measures
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Primary Outcome Measures :
  1. Safety evaluation [ Time Frame: 24 weeks ]
    To determine the overall safety of RNL-JointStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.

  2. WOMAC(Western Ontario and McMaster Universities) Index [ Time Frame: 24 weeks ]
    Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.


Secondary Outcome Measures :
  1. Magnetic Resonance Imaging [ Time Frame: 24 weeks ]
    Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.

  2. KSCRS(Knee Society Clinical rating System) [ Time Frame: 24 weeks ]
    Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).

  3. VAS(11-point box visual analogue scale) [ Time Frame: 24 weeks ]
    Changes in VAS(11-point box visual analogue scale) score.

  4. Histological evaluates [ Time Frame: 24 weeks ]
    Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS II by a blind histopathologist.


Other Outcome Measures:
  1. cartilage volume of the knee joint [ Time Frame: 24 weeks ]
    changes of the cartilage volume of the knee joint measure using a semi-automated segmentation method by a blinded researcher (webappendix)

  2. Arthroscopy [ Time Frame: 24 weeks ]
    Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 6 months after injection

  3. X-ray [ Time Frame: 24 weeks ]
    X-ray perform to measure with Kellgren-Lawrence grade,20 joint space width of the medial compartment,21 mechanical axis with weight bearing line,22 and anatomical axis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study.
  • Age :18-75, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
  • Patients who can't treat with traditional medication and need a arthroplasty.
  • Patients whose lesion is 2~6 cm2 in size.
  • Duration of pain over Grade 4(11-point numeric scale) : > 4 months

Exclusion Criteria:

  • Women who are pregnant or breast feeding or planning to become pregnant during the study.
  • Objects who administer with a anti-inflammatory drugs contain herbal medicine within 14 days prior to inclusion in the study.
  • History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
  • Treatment with intra-articular injection therapy within 2 months prior to screen.
  • Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
  • Positive serology for HIV-1 orHIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
  • Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
  • Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Contacts and Locations
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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): NCT01300598


Locations
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Korea, Republic of
SMG-SNU Boramae Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
R-Bio
Investigators
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Principal Investigator: Kang Sup Yoon, M.D. & Ph.D. SMG-SNU Boramae Hospital
More Information
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Publications of Results:

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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT01300598    
Other Study ID Numbers: Jointstem
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases