Back to resultsA Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis
Primary Purpose
Degenerative Osteoarthritis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TG-C
Placebo Control
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Osteoarthritis focused on measuring hip
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 80 years old
- The subject has a diagnosis of Grade ≤2 primary OA of the target hip
- Pain ≥ 40 on VAS scale
- The subject has groin pain that is elicited by hip rotation on physical examination
- No history of significant organ system disorders.
- Body mass index (BMI) <40 kg/m2
- Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.
- Using birth control
- Written informed consent
Exclusion Criteria:
- The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.
- The subject has severe hip OA ipsilateral to the target hip.
- Previous cartilage transplantation procedure to the injured cartilage surface.
- Major injury to the target hip within 12 months of screening.
- Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening.
- The subject has had surgery on the target hip within the last 6 months.
- Total hip replacement surgery or other surgery on the target hip in the next 12 months.
- MRI indicates bone marrow infiltration, fracture, osteonecrosis/bone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis.
- Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease.
- Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value >8% at the screening Visit.
- Increased risk for post-procedure bleeding or post-procedure infection.
- Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B.
- Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires.
- 1 year history of drug or alcohol abuse.
- Contraindication to or cannot undergo MRI.
- Active malignancy within the last 5 years.
- Pregnant or is lactating.
- Taken steroidal or NSAIDs within 14 days before the Baseline Visit
- Using topical analgesics on the target hip
- Receiving chronic narcotic treatment at screening.
- Received any injection to the target hip within the 3 months before the Baseline Visit.
- Taking antiplatelet or anticoagulants.
- Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months.
- Unable to comply with the requisite study follow-up and all of the follow-up office visits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Active Treatment (TG-C)
Active Treatment 2 (TG-C)
Placebo Control (Normal Saline)
Arm Description
TG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection
TG-C at 3.0 x 10e6 cells per single 2 mL intraarticular injection
Normal saline, single 2 mL intraarticular injection
Outcomes
Primary Outcome Measures
Change in Hip Pain as Assessed by VAS
Assessment of change from baseline in target hip 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
Hip Disability and Osteoarthritis Outcome Score (HOOS)
The HOOS questionnaire was built upon the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC®). Questions from the WOMAC® were used as the basis for the survey, and 2 dimensions were added: sport and recreation and hip-related quality of life. The HOOS is composed of 40 questions in 5 subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items), and Hip-Related Quality of Life (4 items). A total score, ranging from 0 to 100 is calculated. Higher scores represent better functioning.
Timed Up and Go Test (TUG)
The TUG test is used to determine the time needed to progress from sitting to standing and walking. In addition, the test helps to evaluate the probability for falls. The individual starts in a seated position in a chair with armrests and, upon command, stands up, walks 3 meters, turns around, walks back to the chair, and sits down. The time stops when the subject is seated. The use of walking aids should be recorded and kept consistent between tests.
UCLA Activity Score
The UCLA Activity Score includes 10 statements that cover the range of activity states from being "wholly inactive, dependent on others, and cannot leave residence" to "regularly participate in impact sports." The respondents are instructed to select one statement that is most representative of their current activity. Lower scores on the scale reflect a low level of activity and higher scores reflect more activity.
Joint Space Width (JSW) on standing X-ray
To evaluate the effects of 2 dose levels of TG-C on the structural features of the hip joint
WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score
To evaluate the effects of 2 dose levels of TG-C on symptoms of OA of the hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Full Information
NCT ID
NCT05276011
First Posted
March 2, 2022
Last Updated
December 22, 2022
Sponsor
Kolon TissueGene, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05276011
Brief Title
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects With Symptomatic Early Hip Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (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, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 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 hip and determining disease modifying effects of TG-C. TG-C will be compared to normal saline as a control. 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 12 months for both safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Osteoarthritis
Keywords
hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
255 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment (TG-C)
Arm Type
Active Comparator
Arm Description
TG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection
Arm Title
Active Treatment 2 (TG-C)
Arm Type
Active Comparator
Arm Description
TG-C at 3.0 x 10e6 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 Hip Pain as Assessed by VAS
Description
Assessment of change from baseline in target hip 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
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Description
The HOOS questionnaire was built upon the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC®). Questions from the WOMAC® were used as the basis for the survey, and 2 dimensions were added: sport and recreation and hip-related quality of life. The HOOS is composed of 40 questions in 5 subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items), and Hip-Related Quality of Life (4 items). A total score, ranging from 0 to 100 is calculated. Higher scores represent better functioning.
Time Frame
Baseline to Month 12
Title
Timed Up and Go Test (TUG)
Description
The TUG test is used to determine the time needed to progress from sitting to standing and walking. In addition, the test helps to evaluate the probability for falls. The individual starts in a seated position in a chair with armrests and, upon command, stands up, walks 3 meters, turns around, walks back to the chair, and sits down. The time stops when the subject is seated. The use of walking aids should be recorded and kept consistent between tests.
Time Frame
Baseline to Months 1, 3, 6, 9, and 12
Title
UCLA Activity Score
Description
The UCLA Activity Score includes 10 statements that cover the range of activity states from being "wholly inactive, dependent on others, and cannot leave residence" to "regularly participate in impact sports." The respondents are instructed to select one statement that is most representative of their current activity. Lower scores on the scale reflect a low level of activity and higher scores reflect more activity.
Time Frame
Baseline to Months 1, 3, 6, 9, and 12
Title
Joint Space Width (JSW) on standing X-ray
Description
To evaluate the effects of 2 dose levels of TG-C on the structural features of the hip joint
Time Frame
Baseline to Month 12
Title
WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score
Description
To evaluate the effects of 2 dose levels of TG-C on symptoms of OA of the hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Month 12
Other Pre-specified Outcome Measures:
Title
Physical Component Score (PCS) of the Short Form 12-Item Health Survey (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 addresses physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. The mean score is set to 50. Scores >50 indicate better physical or mental health than the mean, and scores <50 indicate worse physical or mental health than the mean.
Time Frame
12 months
Title
Clinician Global Impression of Change (CGI-C)
Description
The CGI-C asks clinicians to choose the response that best describes the overall change in the patient's OA since they received the study medication as "much better," "moderately better," "a little better," "no change," "a little worse," "moderately worse," or" much worse." Clinicians are also asked to indicate if the change that the patient has experienced is clinically meaningful.
Time Frame
Week 1 and Months 1, 3, 6, 9, and 12
Title
Clinician Global Impression of Severity (CGI-S)
Description
clinician to choose the response that best describes the severity of the patient's overall OA as "none," "mild," "moderate," or "severe."
Time Frame
Baseline and at Months 1, 3, 6, 9, and 12
Title
Patient Global Impression of Severity (PGI-S)
Description
patients to select the response that best describes the severity of their OA, their OA-related pain, and their OA-related stiffness and their difficulty with activities as a result of their OA as "none," "mild," "moderate," or "severe."
Time Frame
Baseline and at Months 1, 3, 6, 9, and 12
Title
Patient Global Impression of Change (PGI-C)
Description
patients to choose the response that best describes the overall change in their OA, their OA-related pain, and their OA-related stiffness and the change in their difficulty with activities as a result of their OA since they received the study medication as "much better," "moderately better," "a little better," "no change," "a little worse," "moderately worse," or "much worse." Patients are also asked to indicate if the change that they have experienced is meaningful to them ("yes," "no," or "not applicable" in the case of no change)
Time Frame
Week 1 and Months 1, 3, 6, 9, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 80 years old
The subject has a diagnosis of Grade ≤2 primary OA of the target hip
Pain ≥ 40 on VAS scale
The subject has groin pain that is elicited by hip rotation on physical examination
No history of significant organ system disorders.
Body mass index (BMI) <40 kg/m2
Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.
Using birth control
Written informed consent
Exclusion Criteria:
The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.
The subject has severe hip OA ipsilateral to the target hip.
Previous cartilage transplantation procedure to the injured cartilage surface.
Major injury to the target hip within 12 months of screening.
Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening.
The subject has had surgery on the target hip within the last 6 months.
Total hip replacement surgery or other surgery on the target hip in the next 12 months.
MRI indicates bone marrow infiltration, fracture, osteonecrosis/bone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis.
Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease.
Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value >8% at the screening Visit.
Increased risk for post-procedure bleeding or post-procedure infection.
Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B.
Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires.
1 year history of drug or alcohol abuse.
Contraindication to or cannot undergo MRI.
Active malignancy within the last 5 years.
Pregnant or is lactating.
Taken steroidal or NSAIDs within 14 days before the Baseline Visit
Using topical analgesics on the target hip
Receiving chronic narcotic treatment at screening.
Received any injection to the target hip within the 3 months before the Baseline Visit.
Taking antiplatelet or anticoagulants.
Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months.
Unable to comply with the requisite study follow-up and all of the follow-up office visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Halim, MS
Phone
(301) 921-6000
Ext
187
Email
dhalim@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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis
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