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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
K-Stemcell Co Ltd
ClinicalTrials.gov Identifier:
NCT01300598
First received: February 17, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Degenerative Arthritis
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

Resource links provided by NLM:


Further study details as provided by K-Stemcell Co Ltd:

Primary Outcome Measures:
  • Safety evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.


Secondary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.

  • KSCRS(Knee Society Clinical rating System) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in VAS(11-point box visual analogue scale) score.

  • Histological evaluates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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:
  • cartilage volume of the knee joint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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®
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01300598

Locations
Korea, Republic of
SMG-SNU Boramae Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
K-Stemcell Co Ltd
Investigators
Principal Investigator: Kang Sup Yoon, M.D. & Ph.D. SMG-SNU Boramae Hospital
  More Information

Publications:
Responsible Party: K-Stemcell Co Ltd
ClinicalTrials.gov Identifier: NCT01300598     History of Changes
Other Study ID Numbers: Jointstem
Study First Received: February 17, 2011
Last Updated: March 24, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014