ID

28809

Description

Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02341391

Link

https://clinicaltrials.gov/show/NCT02341391

Keywords

Versions (1)
  1. 2/5/18 2/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Degenerative Arthritis NCT02341391

English

Eligibility Degenerative Arthritis NCT02341391

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. patients aged 45 years or more with grade iv [based on the international cartilage repair society(icrs) evaluation criteria from the mri scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
Description

Age | Osteoarthritis of knee Kellgren-Lawrence score | Conventional Treatment Symptomatic Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C3177117
UMLS CUI [3,1]
C2945704
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C1272705
3. healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
Description

Healthy | Physical Examination Finding Major Absent | Hematology Finding Major Absent | Serum Chemistry Finding Major Absent | Urinalysis Finding Major Absent

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0243095
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0200627
UMLS CUI [3,2]
C0243095
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0332197
UMLS CUI [4,1]
C1883010
UMLS CUI [4,2]
C0243095
UMLS CUI [4,3]
C0205164
UMLS CUI [4,4]
C0332197
UMLS CUI [5,1]
C0042014
UMLS CUI [5,2]
C0243095
UMLS CUI [5,3]
C0205164
UMLS CUI [5,4]
C0332197
4. patients with cartilage damage sized 2-6 cm2 (based on the icrs evaluation criteria from the mri scan results)
Description

Cartilage damage Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0549421
UMLS CUI [1,2]
C0456389
5. voluntarily agreed to participate in this study and signed the informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
Description

Hematology Clinical Significance | Serum Chemistry Measurement Clinical Significance | Urine test results Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0200627
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1883010
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0851020
UMLS CUI [3,2]
C2826293
2. took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
Description

Anti-Inflammatory Agents prescribed | Anti-Inflammatory Agents Non-Prescription Drugs | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0003209
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0003209
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C3846158
3. has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
Description

Drug abuse | Urine drug screening Positive | Blood alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0202274
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0948726
4. received any injection in the target knee within two months before the initiation of the study
Description

Injection Target Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0022742
5. pregnant or breastfeeding female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. with another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, paget's disease adjacent to a joint in the femur or the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
Description

Arthropathy | Exception Degenerative arthritis | Systemic disease Knee | Rheumatism knee | Inflammatory disorder Knee | Calcium pyrophosphate deposition disease | Hemochromatosis | Inflammatory Arthritis | Necrosis Trochanter | Osteitis Deformans Adjacent to Joint Femur | Osteitis Deformans Adjacent to Joint Tibia | Ochronosis | Hemophilic arthropathy | Arthritis, Infectious | Neurogenic arthropathy Knee joint | Villonodular synovitis | Synovial chondroma

Data type

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029408
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0022742
UMLS CUI [4]
C0564818
UMLS CUI [5,1]
C1290884
UMLS CUI [5,2]
C0022742
UMLS CUI [6]
C0553730
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0003864
UMLS CUI [9,1]
C0027540
UMLS CUI [9,2]
C0162370
UMLS CUI [10,1]
C0029401
UMLS CUI [10,2]
C0205117
UMLS CUI [10,3]
C0022417
UMLS CUI [10,4]
C0015811
UMLS CUI [11,1]
C0029401
UMLS CUI [11,2]
C0205117
UMLS CUI [11,3]
C0022417
UMLS CUI [11,4]
C1279118
UMLS CUI [12]
C0028817
UMLS CUI [13]
C0263725
UMLS CUI [14]
C0003869
UMLS CUI [15,1]
C0003892
UMLS CUI [15,2]
C0022745
UMLS CUI [16]
C0158168
UMLS CUI [17]
C0948674
7. with an infectious disease, including hiv or hepatitis (hbv/hcv)
Description

Communicable Disease | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
8. with a history any of the following clinically significant diseases:
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (cabg)]
Description

Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia | Heart Diseases Serious | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003811
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205404
UMLS CUI [5]
C0010055
kidney disease (e.g., chronic renal failure, glomerulonephritis)
Description

Kidney Diseases | Kidney Failure, Chronic | Glomerulonephritis

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0017658
liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
Description

Liver diseases | Liver Cirrhosis | Fatty Liver | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0015695
UMLS CUI [4]
C0341439
endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, cushing's disease)
Description

Endocrine System Diseases | Hyperthyroidism | Hypothyroidism | Thyroiditis | Diabetes Insipidus | Cushing's disease

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0040147
UMLS CUI [5]
C0011848
UMLS CUI [6]
C0221406
insulin-dependent diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
medical history of or current malignant tumor in particular, the tumors that tissuegene-c may aggravate can be screened using the following tests
Description

Malignant Neoplasms | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C3846158
leukemia : white blood cell level in the hematology
Description

Leukemia | White Blood Cell Count procedure Hematology

Data type

boolean

Alias
UMLS CUI [1]
C0023418
UMLS CUI [2,1]
C0023508
UMLS CUI [2,2]
C0200627
osteochondroma, chondromas, chondroblastoma, chondromyxoid fibroma, chondrosarcoma : alkaline phosphatase level in the hematology
Description

Cartilaginous exostosis | Chondroma | Chondroblastoma | Chondromyxoid fibroma | Chondrosarcoma | Alkaline phosphatase measurement Hematology

Data type

boolean

Alias
UMLS CUI [1]
C0029423
UMLS CUI [2]
C0936248
UMLS CUI [3]
C0008441
UMLS CUI [4]
C0221290
UMLS CUI [5]
C0008479
UMLS CUI [6,1]
C0201850
UMLS CUI [6,2]
C0200627
9. participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
10. showed positive drug test results at the screening visit
Description

Drug screen Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1514241
11. did not agree to use a contraceptive method (male and female)
Description

Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Degenerative Arthritis NCT02341391

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. male or female patients
boolean
C0079399 (UMLS CUI [1])
Age | Osteoarthritis of knee Kellgren-Lawrence score | Conventional Treatment Symptomatic Unsuccessful
Item
2. patients aged 45 years or more with grade iv [based on the international cartilage repair society(icrs) evaluation criteria from the mri scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
boolean
C0001779 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
C2945704 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Healthy | Physical Examination Finding Major Absent | Hematology Finding Major Absent | Serum Chemistry Finding Major Absent | Urinalysis Finding Major Absent
Item
3. healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
boolean
C3898900 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0243095 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0200627 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C1883010 (UMLS CUI [4,1])
C0243095 (UMLS CUI [4,2])
C0205164 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0042014 (UMLS CUI [5,1])
C0243095 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
C0332197 (UMLS CUI [5,4])
Cartilage damage Size
Item
4. patients with cartilage damage sized 2-6 cm2 (based on the icrs evaluation criteria from the mri scan results)
boolean
C0549421 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Informed Consent
Item
5. voluntarily agreed to participate in this study and signed the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hematology Clinical Significance | Serum Chemistry Measurement Clinical Significance | Urine test results Clinical Significance
Item
1. showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
boolean
C0200627 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1883010 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0851020 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
Anti-Inflammatory Agents prescribed | Anti-Inflammatory Agents Non-Prescription Drugs | Other Coding
Item
2. took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
boolean
C0003209 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0003209 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Drug abuse | Urine drug screening Positive | Blood alcohol test positive
Item
3. has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
boolean
C0013146 (UMLS CUI [1])
C0202274 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0948726 (UMLS CUI [3])
Injection Target Knee
Item
4. received any injection in the target knee within two months before the initiation of the study
boolean
C1533685 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
5. pregnant or breastfeeding female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Arthropathy | Exception Degenerative arthritis | Systemic disease Knee | Rheumatism knee | Inflammatory disorder Knee | Calcium pyrophosphate deposition disease | Hemochromatosis | Inflammatory Arthritis | Necrosis Trochanter | Osteitis Deformans Adjacent to Joint Femur | Osteitis Deformans Adjacent to Joint Tibia | Ochronosis | Hemophilic arthropathy | Arthritis, Infectious | Neurogenic arthropathy Knee joint | Villonodular synovitis | Synovial chondroma
Item
6. with another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, paget's disease adjacent to a joint in the femur or the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
boolean
C0022408 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0442893 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0564818 (UMLS CUI [4])
C1290884 (UMLS CUI [5,1])
C0022742 (UMLS CUI [5,2])
C0553730 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0003864 (UMLS CUI [8])
C0027540 (UMLS CUI [9,1])
C0162370 (UMLS CUI [9,2])
C0029401 (UMLS CUI [10,1])
C0205117 (UMLS CUI [10,2])
C0022417 (UMLS CUI [10,3])
C0015811 (UMLS CUI [10,4])
C0029401 (UMLS CUI [11,1])
C0205117 (UMLS CUI [11,2])
C0022417 (UMLS CUI [11,3])
C1279118 (UMLS CUI [11,4])
C0028817 (UMLS CUI [12])
C0263725 (UMLS CUI [13])
C0003869 (UMLS CUI [14])
C0003892 (UMLS CUI [15,1])
C0022745 (UMLS CUI [15,2])
C0158168 (UMLS CUI [16])
C0948674 (UMLS CUI [17])
Communicable Disease | HIV Infection | Hepatitis B | Hepatitis C
Item
7. with an infectious disease, including hiv or hepatitis (hbv/hcv)
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Disease Clinical Significance
Item
8. with a history any of the following clinically significant diseases:
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia | Heart Diseases Serious | Coronary Artery Bypass Surgery
Item
heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (cabg)]
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0010055 (UMLS CUI [5])
Kidney Diseases | Kidney Failure, Chronic | Glomerulonephritis
Item
kidney disease (e.g., chronic renal failure, glomerulonephritis)
boolean
C0022658 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0017658 (UMLS CUI [3])
Liver diseases | Liver Cirrhosis | Fatty Liver | Chronic liver disease
Item
liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0015695 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
Endocrine System Diseases | Hyperthyroidism | Hypothyroidism | Thyroiditis | Diabetes Insipidus | Cushing's disease
Item
endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, cushing's disease)
boolean
C0014130 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0040147 (UMLS CUI [4])
C0011848 (UMLS CUI [5])
C0221406 (UMLS CUI [6])
Diabetes Mellitus, Insulin-Dependent
Item
insulin-dependent diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Malignant Neoplasms | Other Coding
Item
medical history of or current malignant tumor in particular, the tumors that tissuegene-c may aggravate can be screened using the following tests
boolean
C0006826 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Leukemia | White Blood Cell Count procedure Hematology
Item
leukemia : white blood cell level in the hematology
boolean
C0023418 (UMLS CUI [1])
C0023508 (UMLS CUI [2,1])
C0200627 (UMLS CUI [2,2])
Cartilaginous exostosis | Chondroma | Chondroblastoma | Chondromyxoid fibroma | Chondrosarcoma | Alkaline phosphatase measurement Hematology
Item
osteochondroma, chondromas, chondroblastoma, chondromyxoid fibroma, chondrosarcoma : alkaline phosphatase level in the hematology
boolean
C0029423 (UMLS CUI [1])
C0936248 (UMLS CUI [2])
C0008441 (UMLS CUI [3])
C0221290 (UMLS CUI [4])
C0008479 (UMLS CUI [5])
C0201850 (UMLS CUI [6,1])
C0200627 (UMLS CUI [6,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
9. participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Drug screen Positive
Item
10. showed positive drug test results at the screening visit
boolean
C0373483 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Contraceptive methods Unwilling
Item
11. did not agree to use a contraceptive method (male and female)
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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