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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

Primary Purpose

Degenerative Osteoarthritis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TG-C
Placebo Control
Sponsored by
Kolon TissueGene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Osteoarthritis focused on measuring knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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
  • Has a score of >=5 on the cartilage feature of the WORMS at Screening
  • MRI exam indicates fracture or tumor
  • Has a positive result on RCR testing at Screening
  • Has taken NSAIDS with 14 days of baseline
  • Has taken steroidal anti-inflammatory medication within 2 months of baseline
  • 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 2 months prior to study entry
  • History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune 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, or non-specified uncontrolled endocrine disorder
  • Uncontrolled diabetes based on a HbA1c > 8% at screening

Sites / Locations

  • Jeffrey DavisRecruiting
  • Bradly GoodmanRecruiting
  • Saima ChohanRecruiting
  • Diraj KarnaniRecruiting
  • Dan LaRecruiting
  • Scott HackerRecruiting
  • Eric GrigsbyRecruiting
  • Arthur MabaquiaoRecruiting
  • Timothy DavisRecruiting
  • Janki TrivediRecruiting
  • Tien-I SuRecruiting
  • Mehul DesaiRecruiting
  • Miguel Telleria
  • David Billmeier
  • Mercedes Ponce De LeonRecruiting
  • Aurelio Torres-ConsuegraRecruiting
  • Edgar GonzalezRecruiting
  • Cathy BarnesRecruiting
  • Anand PatelRecruiting
  • Sandeep Vaid
  • Dennis LevinsonRecruiting
  • Manish JainRecruiting
  • Hythem ShadidRecruiting
  • Adil FatakiaRecruiting
  • Ronald DelanoisRecruiting
  • Melvin ChurchillRecruiting
  • Elena KatzapRecruiting
  • Corey HunterRecruiting
  • Jason OhRecruiting
  • Brett GilbertRecruiting
  • Alan KivitzRecruiting
  • Javad ParviziRecruiting
  • Edward TavelRecruiting
  • Jason HaslamRecruiting
  • Daneshvari Solanki
  • Amr MorsyRecruiting
  • Aldo MasponsRecruiting
  • Subodh BhucharRecruiting
  • Brian MacGillivray
  • David JackRecruiting
  • John HemmersmeierRecruiting
  • James ClarkRecruiting
  • Mark HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Treatment (TG-C)

Placebo Control (Normal Saline)

Arm Description

TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection

Normal saline, single 2 mL intraarticular injection

Outcomes

Primary Outcome Measures

Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
Change in Knee Pain as Assessed by VAS
Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.

Secondary Outcome Measures

MRI Assessment of Target Knee
Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI
PCS of the SF-12 Questionnaire
Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (SF-12v2®) questionnaire
WOMAC Total Score
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Health Assessment Questionnaire Disability Index
Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)

Full Information

First Posted
June 21, 2017
Last Updated
September 25, 2023
Sponsor
Kolon TissueGene, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03203330
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kolon TissueGene, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 with annual cancer surveillance questionnaires through 15 years post dosing for subjects who do not enroll in the Long Term Safety study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Osteoarthritis
Keywords
knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment (TG-C)
Arm Type
Active Comparator
Arm Description
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Arm Title
Placebo Control (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
Normal saline, single 2 mL intraarticular injection
Intervention Type
Biological
Intervention Name(s)
TG-C
Other Intervention Name(s)
TissueGene-C
Intervention Description
2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.
Intervention Type
Biological
Intervention Name(s)
Placebo Control
Other Intervention Name(s)
Normal Saline
Intervention Description
2 mL normal saline injection
Primary Outcome Measure Information:
Title
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
Description
Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
Time Frame
12 months
Title
Change in Knee Pain as Assessed by VAS
Description
Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MRI Assessment of Target Knee
Description
Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI
Time Frame
12 months
Title
PCS of the SF-12 Questionnaire
Description
Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (SF-12v2®) questionnaire
Time Frame
12 months
Title
WOMAC Total Score
Description
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Time Frame
24 months
Title
Health Assessment Questionnaire Disability Index
Description
Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Radiography for Structural Change in Knee Joint
Description
Evaluate structural changes of the knee joint as determined by radiography (X-ray)
Time Frame
Through 24 months
Title
Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score
Description
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Time Frame
At Months 3, 6, 9 and 18
Title
Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores
Description
Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores
Time Frame
Through 24 months
Title
Efficacy of TG-C with Regard to Knee Function via VAS Pain Score
Description
Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12
Time Frame
At Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24
Title
OMERACT-OARSI Responder Analysis
Description
Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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 Written informed consent Using birth control Exclusion Criteria: Knee symptoms that result in difficulty or inability to walk Knee effusion >2+ Has Grade 3 OARSI JSN Has a score of 0 or >=5 on the cartilage feature of the WORMS at Screening MRI exam indicates fracture or tumor Has a positive result on RCR testing at Screening Has taken NSAIDS with 14 days of baseline Has taken steroidal anti-inflammatory medication within 2 months of baseline 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 2 months prior to study entry History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune 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, or non-specified uncontrolled endocrine disorder Uncontrolled diabetes based on a HbA1c > 8% at screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Harrison
Phone
(910) 399-3238
Email
KTGclinical@tissuegene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moon Jong Noh, PhD
Organizational Affiliation
Kolon TissueGene, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Jeffrey Davis
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Bradly Goodman
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Name
Saima Chohan
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Diraj Karnani
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Name
Dan La
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Name
Scott Hacker
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Eric Grigsby
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthur Mabaquiao
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Individual Site Status
Recruiting
Facility Name
Timothy Davis
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Name
Janki Trivedi
City
Sun City
State/Province
California
ZIP/Postal Code
92586
Country
United States
Individual Site Status
Recruiting
Facility Name
Tien-I Su
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Name
Mehul Desai
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Individual Site Status
Recruiting
Facility Name
Miguel Telleria
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
David Billmeier
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mercedes Ponce De Leon
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Aurelio Torres-Consuegra
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Edgar Gonzalez
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Cathy Barnes
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Name
Anand Patel
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Sandeep Vaid
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dennis Levinson
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
Manish Jain
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Hythem Shadid
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Individual Site Status
Recruiting
Facility Name
Adil Fatakia
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Ronald Delanois
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Name
Melvin Churchill
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Recruiting
Facility Name
Elena Katzap
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
Corey Hunter
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Jason Oh
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Brett Gilbert
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Recruiting
Facility Name
Alan Kivitz
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Javad Parvizi
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Edward Tavel
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Individual Site Status
Recruiting
Facility Name
Jason Haslam
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Daneshvari Solanki
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Amr Morsy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Individual Site Status
Recruiting
Facility Name
Aldo Maspons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79225
Country
United States
Individual Site Status
Recruiting
Facility Name
Subodh Bhuchar
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Brian MacGillivray
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
David Jack
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
John Hemmersmeier
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
James Clark
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Individual Site Status
Recruiting
Facility Name
Mark Hermann
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33229973
Citation
Mehta S, He T, Bajpayee AG. Recent advances in targeted drug delivery for treatment of osteoarthritis. Curr Opin Rheumatol. 2021 Jan;33(1):94-109. doi: 10.1097/BOR.0000000000000761.
Results Reference
derived

Learn more about this trial

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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