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Trial record 9 of 9 for:    tissuegene

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee

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ClinicalTrials.gov Identifier: NCT03203330
Recruitment Status : Not yet recruiting
First Posted : June 29, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
TissueGene, Inc.

Brief Summary:
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.

Condition or disease Intervention/treatment Phase
Degenerative Osteoarthritis Biological: TG-C Biological: Placebo Control Phase 3

Detailed Description:
This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is intended for the treatment of patients with KL Grade 2 and 3 osteoarthritis and OARSI JSN Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS), function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This is a placebo-controlled study, TG-C will be compared to normal saline as a control. Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 24 months for both safety and efficacy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active Treatment (TG-C)
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Biological: TG-C
2 mL injection of allogeneic human chondrocytes expressing transforming growth factor-beta1
Other Name: TissueGene-C
Placebo Comparator: Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
Biological: Placebo Control
2 mL normal saline injection
Other Name: Normal Saline



Primary Outcome Measures :
  1. Change in Knee Function as Assessed by WOMAC [ Time Frame: 12 and 24 months ]
    Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index

  2. Change in Knee Pain as Assessed by VAS [ Time Frame: 12 and 24 months ]
    Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) Scoring of Knee Symptoms, Pain and Function [ Time Frame: 12 and 24 months ]
    Evaluation of target knee symptoms, joint pain, and functionality assessed using the IKDC Subjective knee evaluation

  2. Change in Joint Space Width [ Time Frame: 12 and 24 months ]
    Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography

  3. PCS of the SF-12 Questionnaire [ Time Frame: 12 and 24 months ]
    Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.

  4. Health Assessment Questionnaire Disability Index [ Time Frame: Through 24 months ]
    Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)


Other Outcome Measures:
  1. MRI Assessment of Target Knee [ Time Frame: 6, 12 and 24 months ]
    Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)

  2. OMERACT-OARSI Responder Analysis [ Time Frame: 12 and 24 months ]
    Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria

  3. Incidence and Severity of Injection Site Reactions [ Time Frame: Through 24 months ]
    Incidence and severity of swelling, irritation, or other reactions at the site of administration

  4. Incidence and Severity of Adverse Events (AEs) [ Time Frame: Through 24 months ]
    Incidence and severity of adverse events assess after treatment

  5. Radiography for Osteophytes [ Time Frame: 12 and 24 months ]
    Radiography for assessment of change from baseline in osteophytes by OARSI criteria

  6. Changes in Laboratory Tests [ Time Frame: Through 24 months ]
    Changes from baseline in clinical laboratory test results

  7. Biochemical Biomarker Analysis [ Time Frame: Through 24 months ]
    Assessment of changes from baseline in biochemical biomarkers of knee osteoarthritis

  8. Frequency of Analgesia Use [ Time Frame: Through 24 months ]
    Evaluation of the frequency and dose of analgesia or anti-inflammatory medication use

  9. MCS of the SF-12 Questionnaire [ Time Frame: Through 24 months ]
    Evaluation of the change from baseline in the eight domains of the mental component score (MCS) of the SF-12v2 questionnaire



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 40 or older
  • BMI between 18.5 and 40
  • KL Grade 2 or 3 knee OA
  • OARSI Grade 1 or 2 medial JSN
  • Pain >= 40 on VAS scale
  • WOMAC score <=70 for target knee
  • Written informed consent
  • Using birth control

Exclusion Criteria:

  • Knee symptoms that result in difficulty or inability to walk
  • Knee effusion >2+
  • Has Grade 0 OARSI JSN or atrophic OA
  • MRI exam indicates fracture or tumor
  • Has taken NSAIDS with 14 days of baseline
  • Has taken steroidal anti-inflammatory medication within 2 months of baseline
  • Currently using topical analgesics on target knee
  • Chronic (>21 days) narcotic use
  • Recent history (within 1 year) of drug or alcohol abuse
  • Pregnant or lactating
  • Has received injection to target knee within 3 months prior to study entry
  • Is contraindicated or cannot undergo for 3 Tesla (3T) MRI
  • History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, immune OA, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
  • Severe hip osteoarthritis ipsilateral to the target knee
  • Ongoing infection disease including but not limited to HIV, Hepatitis B or C.
  • Clinically significant congestive heart failure hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, uncontrolled diabetes.
  • At risk for post procedure bleeding or infection
  • Is taking anti-platelets or anti-coagulants (low-dose aspirin permitted)
  • Has had an active malignancy with the last 5 years.
  • Previous cartilage repair procedures
  • Major injury to the target knee within 12 months of screening
  • Active ulcer or infection on the skin of the target knee within 1 month of screening
  • Surgery on the target knee within 6 months of screening
  • Varus or valgus of the target knee >10 degrees
  • Has total knee arthroplasty or other knee surgery planned within the next 12 months.
  • Participation in another investigation study within 3 months
  • Unable to complete requisite follow-up and 3T MRI exams
  • Has cognitive impairment or cannot otherwise provide informed consent or answer questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203330


Contacts
Contact: Robert Casper, MS (301) 921-6000 ext 173 rcasper@tissuegene.com
Contact: Gurdyal Kalsi, MD (301) 921-6000 ext 160 gkalsi@tissuegene.com

Sponsors and Collaborators
TissueGene, Inc.
Investigators
Principal Investigator: Michael Mont, MD The Cleveland Clinic

Responsible Party: TissueGene, Inc.
ClinicalTrials.gov Identifier: NCT03203330     History of Changes
Other Study ID Numbers: TGC12301
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases