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

June 3, 2019 updated by: R-Bio

Safety and Efficacy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging
Time Frame: 24 weeks
Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
24 weeks
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).
24 weeks
VAS(11-point box visual analogue scale)
Time Frame: 24 weeks
Changes in VAS(11-point box visual analogue scale) score.
24 weeks
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.
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 weeks
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
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Bio

Investigators

  • Principal Investigator: Kang Sup Yoon, M.D. & Ph.D., SMG-SNU Boramae Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jointstem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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