Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis
2. juli 2018 opdateret af: Kolon Life Science
A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.
And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.
During clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female patients
- 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
- Healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
- Patients with cartilage damage sized 2-6 cm2 (based on the ICRS evaluation criteria from the MRI scan results)
- Voluntarily agreed to participate in this study and signed the informed consent form
Exclusion Criteria:
- Showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
- Took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
- 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
- Received any injection in the target knee within two months before the initiation of the study
- Pregnant or breastfeeding female
- 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)
- With an infectious disease, including HIV or hepatitis (HBV/HCV)
With a history any of the following clinically significant diseases:
- heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
- kidney disease (e.g., chronic renal failure, glomerulonephritis)
- liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
- endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, Cushing's disease)
- insulin-dependent diabetes mellitus
medical history of or current malignant tumor In particular, the tumors that TissueGene-C may aggravate can be screened using the following tests
- Leukemia : White Blood Cell level in the hematology
- Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma, Chondrosarcoma : Alkaline phosphatase level in the hematology
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Showed positive drug test results at the screening visit
- Did not agree to use a contraceptive method (male and female)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: TissueGene-C(Low dose)
Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells
|
3.0 x 10^6 cells
|
|
Eksperimentel: TissueGene-C(Medium dose)
Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells
|
1.0 x 10^7 cells
|
|
Eksperimentel: TissueGene-C(High dose)
Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells
|
3.0 x 10^7 cells
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Adverse Events after the administration of TissueGene-C
Tidsramme: 6 months
|
Number of Participants with Adverse Events after the administration of TissueGene-C
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in MRI scan
Tidsramme: before and 28 days, 3 months, and 6 months
|
Change in the MRI scan results after the administration of TissueGene-C
|
before and 28 days, 3 months, and 6 months
|
|
Change in the Knee Society Clinical Rating System(KSCRS) test results
Tidsramme: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Comparative Evaluation of knee exam
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Changes in WOMAC scores
Tidsramme: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities(WOMAC)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Changes in 100 mm-VAS
Tidsramme: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Tidsramme: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
|
Replication-competent retrovirus test (RCR test)
Tidsramme: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Replication-competent retrovirus test (RCR test)
|
before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2007
Primær færdiggørelse (Faktiske)
1. august 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
8. januar 2015
Først indsendt, der opfyldte QC-kriterier
16. januar 2015
Først opslået (Skøn)
19. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TGC-KI-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .