Back to resultsAutologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Primary Purpose
Degenerative Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous Adipose Tissue derived MSCs Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Arthritis
Eligibility 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.
Sites / Locations
- SMG-SNU Boramae Hospital
Outcomes
Primary Outcome Measures
Safety evaluation
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
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
Secondary Outcome Measures
Magnetic Resonance Imaging
Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
KSCRS(Knee Society Clinical rating System)
Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).
VAS(11-point box visual analogue scale)
Changes in VAS(11-point box visual analogue scale) score.
Histological evaluates
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300598
Brief Title
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Official Title
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Other Intervention Name(s)
RNL-JointStem®
Intervention Description
Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
Primary Outcome Measure Information:
Title
Safety evaluation
Description
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.
Time Frame
24 weeks
Title
WOMAC(Western Ontario and McMaster Universities) Index
Description
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Description
Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
Time Frame
24 weeks
Title
KSCRS(Knee Society Clinical rating System)
Description
Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).
Time Frame
24 weeks
Title
VAS(11-point box visual analogue scale)
Description
Changes in VAS(11-point box visual analogue scale) score.
Time Frame
24 weeks
Title
Histological evaluates
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
cartilage volume of the knee joint
Description
changes of the cartilage volume of the knee joint measure using a semi-automated segmentation method by a blinded researcher (webappendix)
Time Frame
24 weeks
Title
Arthroscopy
Description
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 6 months after injection
Time Frame
24 weeks
Title
X-ray
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Sup Yoon, M.D. & Ph.D.
Organizational Affiliation
SMG-SNU Boramae Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24449146
Citation
Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634. Erratum In: Stem Cells. 2017 Jun;35(6):1651-1652.
Results Reference
result
PubMed Identifier
28746812
Citation
Jo CH, Chai JW, Jeong EC, Oh S, Shin JS, Shim H, Yoon KS. Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee: A 2-Year Follow-up Study. Am J Sports Med. 2017 Oct;45(12):2774-2783. doi: 10.1177/0363546517716641. Epub 2017 Jul 26.
Results Reference
result
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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
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