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

NCT01221441 | Completed Phase 2 Results DMC

• 1 other identifier: TGC09201
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoarthritis, Knee

Keywords

Cartilage; Knee; Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year

  Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.

  1 Year

• Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year

  Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.

  1 Year

Secondary Outcomes (11)

• Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years

  2 Years

• Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years

  2 Years

• Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year

  1 Year

• Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire

  2 Years

• Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia

  2 Years

Study Arms (2)

TissueGene-C

EXPERIMENTAL

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

Biological: TissueGene-C

Placebo Control

PLACEBO COMPARATOR

Normal Saline injection

Drug: Normal Saline

Interventions

TissueGene-C BIOLOGICAL

Single intraarticular injection at 3 x 10e7 cells

Also known as: TG-C

TissueGene-C

Normal Saline DRUG

Single intraarticular injection of normal saline as a placebo control

Also known as: 0.9% Saline

Placebo Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female subject
• Age 18 to 70 years
• 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.
• 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 should be between 90-160mm. Hg, and Diastolic Blood Pressure between 50-90mm.Hg,
• Patients with Grade 3 chronic osteoarthritis of the knee as determined by the Radiographic Criteria of Kellgren and Lawrence.
• Symptom of pain for more than four (4) consecutive months and intensity of ≥ 40 and ≤ 90 on the 100-mm scale.
• Patients should be cleared to use protocol specified equipment: 3T MRI.
• Patients providing written informed consent after the nature of the study is fully explained and understood by the patient.

You may not qualify if:

• Age 71 or older
• Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
• Patients taking non-steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out as per section 3.6.4 above.
• Patients taking steroidal anti-inflammatory medications within 2 months of baseline visit.
• Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug test at the time of screening.
• Patients receiving injections to the treated knee within 2 months prior to study entry
• Patients who are contraindicated for 3T MRI.
• 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, synovial chondromatosis, and/or history of inflammatory arthropathy.
• Patients with ongoing infectious disease, including HIV and hepatitis B or C.
• 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.
• 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.

Sponsors & Collaborators

• Kolon TissueGene, Inc.: lead

Study Sites (5)

Advent Clinical Research

Pinellas Park, Florida, 33781, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University Orthopedics

State College, Pennsylvania, 16801, United States

Location

Commonwealth Orthopedics

Arlington, Virginia, 22205, United States

Location

Related Publications (2)

• 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.

  PMID: 29145839 DERIVED

• 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.

  PMID: 26188189 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

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

ocopeland@tissuegene.com

(301) 921-6000

Study Officials

• Michael A Mont, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

• David W Romness, MD

  Commonwealth Orthopedics, Virginia Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 15, 2010
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (5)