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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

Tracking Information
First Submitted Date  ICMJE February 17, 2011
First Posted Date  ICMJE February 21, 2011
Last Update Posted Date June 5, 2019
Study Start Date  ICMJE December 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01300598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • Magnetic Resonance Imaging [ Time Frame: 24 weeks ]
    Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
  • 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).
  • VAS(11-point box visual analogue scale) [ Time Frame: 24 weeks ]
    Changes in VAS(11-point box visual analogue scale) score.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
  • Magnetic Resonance Imaging [ Time Frame: 24 weeks ]
    Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
  • 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).
  • VAS(11-point box visual analogue scale) [ Time Frame: 24 weeks ]
    Changes in VAS(11-point box visual analogue scale) score.
  • Histological evaluates [ Time Frame: 24 weeks ]
    Histological evaluates about regenerated tissues.
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2012)
  • 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)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Official Title  ICMJE Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Arthritis
Intervention  ICMJE 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®
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01300598
Other Study ID Numbers  ICMJE Jointstem
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R-Bio
Study Sponsor  ICMJE R-Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kang Sup Yoon, M.D. & Ph.D. SMG-SNU Boramae Hospital
PRS Account R-Bio
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP