Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee - Full Text View

Sponsored by:	TissueGene, Inc.
Information provided by:	TissueGene, Inc.
ClinicalTrials.gov Identifier:	NCT00599248

Purpose

The study is being conducted to investigate the safety and activity of TissueGene-C injected into the knee joint of patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement.

Condition	Intervention	Phase
Osteoarthritis, Knee	Biological: TissueGene-C Biological: Placebo	Phase I

MedlinePlus related topics: Joint Disorders Knee Replacement Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:	A Phase 1 Study to Determin the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty

Further study details as provided by TissueGene, Inc.:

Primary Outcome Measures:

The incidence and severity of observations at the site of administration, the incidence and severity of adverse events assessed through 28 days after treatment and changes in clinical lab measurements [ Time Frame: Days 0, 3, 7, 11, 28, 29 and at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production. [ Time Frame: 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint	Biological: TissueGene-C TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
2: Placebo Comparator Placebo control	Biological: Placebo Placebo control (DMEM)

Detailed Description:

The purpose of this first human study is to investigate the safety and biological activity of intra-articularly applied TissueGene-C in patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement. In addition, data on joint pain, range of motion, and functionality will be obtained in this patient population prior to total knee replacement.

The primary objective of this study is to evaluate the safety and biological activity of intra-articularly administered TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities affecting the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests as compared to the placebo control.

The secondary objectives of this study are to:

Evaluate the dose response of the hChonJb#7 cells in grafting at the defect as compared to the placebo control.
Evaluate distribution of hChonJb#7 cells out of the injection site.
Evaluate the regeneration of hyaline cartilage as determined by the histological analysis of the resected knee tissue.
Evaluate the joint for evidence of tissue overgrowth or transformation.
Evaluate the biological activity of TissueGene-C on joint pain, range of motion and functionality as compared to the placebo control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female subjects
Age 18 years and older
In general good health as evidenced by physical examination, normal hematology, serum chemistry, and urinalysis screening laboratory results, and a negative history of significant organ system disorders. All laboratory values must be within 20% of normal ranges.
Patients with Degenerative Joint Disease (DJD) of the knee that is refractory to existing drug therapies and who are scheduled for Total Knee Arthroplasty.
Based on Radiographic findings, defect should be more than 2 cm.
Patients providing written informed consent, after the nature of the study, are fully explained.
Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.
Blood Pressure measurements - Systolic Blood Pressure (SBP) should be between 90-160mm. Hg, and Diastolic Blood Pressure (DBP) between 50-90mm.Hg,
Osteoarthritis confirmed by the Radiographic Criteria of Kellgren and Lawrence
Symptom of pain for more than four (4) consecutive months and intensity greater than Grade 4 on the 11-point numeric scale.

Exclusion Criteria:

Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results
Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit
Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug/alcohol test at the time of screening
Patients receiving injections to the treated knee within 2 months prior to study entry
Patients who are pregnant or currently breast-feeding children
Patients with systemic, rheumatic, or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, necrosis of the femoral condyle, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
Patients with ongoing infectious disease, including HIV and hepatitis
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes
Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
Positive drug screen at screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599248

Contacts

Contact: Scott Rodgers

301-337-4991

Scott.Rodgers@sgs.com

Locations

United States, Maryland
Sinai Hospital of Baltimore	Recruiting
Baltimore, Maryland, United States, 21215
Contact: Rivka Gutterman, RN 410-601-8257 Rgutterm@lifebridgehealth.org
Contact: Florante Santos, MD 410-601-8609 fsantos@lifebrigdehealth.org
Principal Investigator: Michael Mont, MD
United States, Virginia
Commonwealth Orthopedics	Not yet recruiting
Arlington, Virginia, United States, 22205
Contact: Deborah Tominack, RN 703-525-6100 trialsva@erols.com
Principal Investigator: David Romness, MD

Sponsors and Collaborators

TissueGene, Inc.

Investigators

Principal Investigator:	Michael Mont, MD	Sinai Hospital of Baltimore
Principal Investigator:	David Romness, MD	Commonwealth Orthopedics, Virginia Hospital Center

More Information

Responsible Party:	TissueGene, Inc. ( R. Ogden Copeland/Director, Regulatory Affairs )
Study ID Numbers:	TGC-03-01
Study First Received:	January 11, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00599248
Health Authority:	United States: Food and Drug Administration

Keywords provided by TissueGene, Inc.:

osteoarthritis, knee

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009