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Completed

NCT Number: NCT01300598

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SMG-SNU Boramae Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Adipose Tissue derived MSCs Transplantation

Procedure

Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL

Other names: RNL-JointStem®

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Registry information

Official study title

Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 21, 2011
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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