A Phase 1, Open-label, Dose-ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of Signature Cord Product in Patients With Symptomatic Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
研究概览
简要总结
This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2 clinics on 135 knees.
详细描述
Primary Objective:
A Phase 1, open-label, non-controlled trial, to assess the safety of intra-articular injection of SIG001, at either of two doses, in a total of 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days after dosing.
Secondary Objective:
A Phase 1, open-label, non-controlled trial, to obtain very early data relating to any effects of intra-articular injection of SIG001, at either of two doses pain, activity, and quality of life in 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of osteoarthritis of the knee based on clinical and radiographic findings
- •Kellgren-Lawrence Grades 2-3
- •Average pain score, on a 100-point numerical rating scale (VAS), over the past 7 days of > 40 and < 90 in the index knee and < 40 in the contralateral knee
- •Body mass index < 35 kg/m²
- •Ability to comply with the requirements of the study
- •Ability to understand and provide written informed consent
- •Not suspecting or expecting to be pregnant during the study period
- •All participants of reproductive age/capacity to confirm the use of adequate contraception during the study period
排除标准
- •Prior therapeutic radiation to the index knee
- •Use of any pain medication or therapy less (anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDS) oral and topical, topical CBD, and narcotics) than 15 days prior to test product administration that has not or will not have had a stable dosage, frequency, or intensity for at least 3 months prior to test agent administration. Use of oral NSAIDs at a stable dose at least 3 months prior to test agent administration must be continued through the study period.
- •Intra-articular treatment with corticosteroids, regenerative medicines (e.g., plasma, stem cell, placental products), or systemic steroid use within 3 months prior to screening
- •Intra-articular treatment with hyaluronic acid within 6 months prior to screening
- •Surgical intervention on the index knee < 12 months, or arthroscopy < 3 months prior to screening
- •Non-ambulatory status
- •Past or current diagnosis of fibromyalgia or inflammatory arthritis, gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, active infection of the index knee joint or at the site of injection, pes anserine bursitis, neurogenic or vascular claudication, or uncontrolled diabetes mellitus (HbA1C>8%)
- •Diagnosis of arthritis due to traumatic injury or meniscal tear in the index knee within 2 years of screening
- •Moderate or large knee effusion in the index knee at screening and at test agent administration that requires drainage for diagnostic purposes or symptomatic relief
- •Clinically significant, ongoing illness or medical condition that in the opinion of the investigator constitutes a safety risk for participation in the study or that could interfere with achieving the study objectives, conduct or evaluation
- •Females who are pregnant or lactating
- •Regular use of anticoagulants (daily use of aspirin ≦ 325 mg is acceptable)
- •Active alcohol or substance abuse or any other reason that makes it unlikely that the subject will comply with study procedures
- •Subjects with a psychiatric illness or condition, which, in the opinion of the investigation, would interfere with the conduct of the study or the interpretation of study results. Subjects with stable anxiety and depression defined as being on stable doses of antidepressant and anxiety drugs for the last 6 months and for which no dose changes are expected during the study can be included.
- •Clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to adversely affect the subject's risk-benefit or interfere with study compliance or assessment of safety or efficacy.
- •Known allergy to local anesthetics or components of the study drug.
- •Subjects with autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or Human Immunodeficiency Virus (HIV).
结局指标
主要结局
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
时间窗: 90 days
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
次要结局
- Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline(90 days and six months)
研究者
Thomas Klootwyk, MD
Orthopedic Surgeon
Forte Sports Medicine and Orthopedics