Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

NCT ID: NCT01221441

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

Detailed Description

Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection.

The objectives of this study are to:

1. Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain.

2. Evaluate the safety of administration of a single intra-articular dose of TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities, the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests, including immune analyses.

3. Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication.

4. Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI).

5. Evaluate distribution of hChonJb#7 cells out of the injection site.

6. Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TissueGene-C

TissueGene-C at 3 x 10e7 cells per injection (intraarticular)

Group Type: EXPERIMENTAL

TissueGene-C

Intervention Type: BIOLOGICAL

Single intraarticular injection at 3 x 10e7 cells

Placebo Control

Normal Saline injection

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Single intraarticular injection of normal saline as a placebo control

Interventions

TissueGene-C

Single intraarticular injection at 3 x 10e7 cells

Intervention Type: BIOLOGICAL

Normal Saline

Single intraarticular injection of normal saline as a placebo control

Intervention Type: DRUG

Other Intervention Names

TG-C; 0.9% Saline

Eligibility Criteria

Inclusion Criteria

1. Male or Female subject

2. Age 18 to 70 years

3. 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.

1. Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.

2. Blood Pressure measurements - Systolic Blood Pressure should be between 90-160mm. Hg, and Diastolic Blood Pressure between 50-90mm.Hg,

4. Patients with Grade 3 chronic osteoarthritis of the knee as determined by the Radiographic Criteria of Kellgren and Lawrence.

5. Symptom of pain for more than four (4) consecutive months and intensity of ≥ 40 and ≤ 90 on the 100-mm scale.

6. Patients should be cleared to use protocol specified equipment: 3T MRI.

7. Patients providing written informed consent after the nature of the study is fully explained and understood by the patient.

Exclusion Criteria

1. Age 71 or older

2. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.

3. Patients taking non-steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out as per section 3.6.4 above.

4. Patients taking steroidal anti-inflammatory medications within 2 months of baseline visit.

5. Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug test at the time of screening.

6. Patients receiving injections to the treated knee within 2 months prior to study entry

7. Patients who are contraindicated for 3T MRI.

8. Patients who are pregnant or currently breast-feeding children.

9. 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, synovial chondromatosis, and/or history of inflammatory arthropathy.

10. Patients with ongoing infectious disease, including HIV and hepatitis B or C.

11. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes.

12. Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

13. Patients that will be unable to comply with the requisite study follow-up and are not able to complete all of the follow-up office visits and 3T MRI exams.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kolon TissueGene, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Mont, MD

Role: PRINCIPAL_INVESTIGATOR

Sinai Hospital of Baltimore

David W Romness, MD

Role: PRINCIPAL_INVESTIGATOR

Commonwealth Orthopedics, Virginia Hospital Center

Locations

Advent Clinical Research

Pinellas Park, Florida, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

University Orthopedics

State College, Pennsylvania, United States

Commonwealth Orthopedics

Arlington, Virginia, United States

Countries

United States

References

Guermazi A, Kalsi G, Niu J, Crema MD, Copeland RO, Orlando A, Noh MJ, Roemer FW. Structural effects of intra-articular TGF-beta1 in moderate to advanced knee osteoarthritis: MRI-based assessment in a randomized controlled trial. BMC Musculoskelet Disord. 2017 Nov 16;18(1):461. doi: 10.1186/s12891-017-1830-8.

Reference Type: DERIVED

PMID: 29145839 (View on PubMed)

Cherian JJ, Parvizi J, Bramlet D, Lee KH, Romness DW, Mont MA. Preliminary results of a phase II randomized study to determine the efficacy and safety of genetically engineered allogeneic human chondrocytes expressing TGF-beta1 in patients with grade 3 chronic degenerative joint disease of the knee. Osteoarthritis Cartilage. 2015 Dec;23(12):2109-2118. doi: 10.1016/j.joca.2015.06.019. Epub 2015 Jul 16.

Reference Type: DERIVED

PMID: 26188189 (View on PubMed)

Other Identifiers

TGC09201

Identifier Type: -

Identifier Source: org_study_id