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

NCT00599248 | Completed Phase 1 Results DMC

• 1 other identifier: TGC-03-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, knee

Outcome Measures

Primary Outcomes (1)

• Summary of Adverse Events

  The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.

  Through 28 days post-dosing

Secondary Outcomes (5)

• Number of Patients Showing Engraftment at the Defect

  28 Days

• Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site

  12 Months

• Number of Participants With Observable Evidence of Cartilage Regeneration

  Days 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

• Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint

  29

• Number of Patients With Improvements in Pain and Function of the Knee Joint

  28 Days

Study Arms (4)

1

EXPERIMENTAL

TissueGene-C single intraarticular injection of 3x10e6 cells/joint

Biological: TissueGene-C

2

EXPERIMENTAL

TissueGene-C single intraarticular injection of 1x10e7 cells/joint

Biological: TissueGene-C

3

EXPERIMENTAL

TissueGene-C single intraarticular injection of 3x10e7 cells/joint

Biological: TissueGene-C

4

PLACEBO COMPARATOR

Placebo control single intraarticular injection

Biological: Placebo

Interventions

TissueGene-C BIOLOGICAL

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

1; 2; 3

Placebo BIOLOGICAL

Placebo control (DMEM)

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kolon TissueGene, Inc.: lead

Study Sites (2)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Commonwealth Orthopedics

Arlington, Virginia, 22205, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

This study was designed a a preliminary assessment of safety in a limited population (12 subjects: 9 active 3 placebo) therefore statistics are presented descriptively.

Results Point of Contact

• Title: R. Ogden Copeland
• Organization: TissueGene, Inc

ocopeland@tissuegene.com

(301) 921-6000

Study Officials

• Michael Mont, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

• David Romness, MD

  Commonwealth Orthopedics, Virginia Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: July 7, 2017
• Results First Posted: June 30, 2016

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)