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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 255
- 主要终点
- Change in Hip Pain as Assessed by VAS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
干预措施: Placebo Control (Biological)
Active Treatment (TG-C)
TG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection
干预措施: TG-C (Biological)
Active Treatment 2 (TG-C)
TG-C at 3.0 x 10e6 cells per single 2 mL intraarticular injection
干预措施: TG-C (Biological)
结局指标
主要结局
Change in Hip Pain as Assessed by VAS
时间窗: Baseline to Month 12
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.
次要结局
- UCLA Activity Score(Baseline to Months 1, 3, 6, 9, and 12)
- Joint Space Width (JSW) on standing X-ray(Baseline to Month 12)
- WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score(Baseline to Month 12)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)(Baseline to Month 12)
- Timed Up and Go Test (TUG)(Baseline to Months 1, 3, 6, 9, and 12)