Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

Sponsor

Kolon Life Science (Industry)

Overall Status

Completed

CT.gov ID

NCT01671072

Collaborator

(none)

Enrollment

Locations

Arms

18.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis	Biological: TissueGene-C Drug: Normal Saline	Phase 2

Detailed Description

TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues.

In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for the presence of adverse events.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TissueGene-C Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells	Biological: TissueGene-C TissueGene-C at 1.8 x 10^7 cells
Placebo Comparator: Normal Saline Single intra-articular injection to the damaged knee joint at the same volume	Drug: Normal Saline Sodium chloride 0.9%, 3.5ml

Arm

Intervention/Treatment

Experimental: TissueGene-C

Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells

Biological: TissueGene-C

TissueGene-C at 1.8 x 10^7 cells

Placebo Comparator: Normal Saline

Single intra-articular injection to the damaged knee joint at the same volume

Drug: Normal Saline

Sodium chloride 0.9%, 3.5ml

Outcome Measures

Primary Outcome Measures

Changes in IKDC Subjective Score. [Week 0 and 24]
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

Secondary Outcome Measures

Changes in WOMAC scores. [Week 0 and 24]
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Changes in KOOS scores. [Week 0 and 24]
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Changes in 100 mm-VAS. [Week 0 and 24]
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
MRI scan [Week 0 and 24]
Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 following dosing by an independent radiographic reviewer.
Proportion of Patients Use of Rescue Medication [Week 4, 12 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Female or male aged 18 years or more
Diagnosed with degenerative arthritis of the knee
With an IKDC score of 60 or lower at the screening visit
With Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
With a Body Mass Index(BMI) of higher than18.5 and lower than 30
With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
With no alleviation of the symptoms even after at least three months of non-surgical treatment
Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
Agreed to use an effective contraceptive method during the study period
Voluntarily agreed to participate in this study, and signed the informed consent form

Exclusion Criteria:

Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
Falls under Inclusion Criteria 6 but with the damage in the relevant lesion considered ICRS Grade IV sized more than 6 cm2
Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
With a history of drug abuse within one year prior to enrollment in this study, or showed positive results in the urine drug test or the serum alcohol test at the screening visit
Received an injection in the target knee within two months before enrollment in this 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 tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)
With an infectious disease, including HIV or hepatitis
With any of the following clinically significant diseases:

heart disease [e.g., myocardial infarction, arrhythmia, other serious heart diseases, 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 past 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
Considered inappropriate by the investigator for participation in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Gangnam-gu	Seoul	Korea, Republic of	135-710
2	Seoul National Univ. Hospital	Seoul		Korea, Republic of	110-744
3	Asan Medical Center	Seoul		Korea, Republic of	138-736