NCT04750252尚未招募1 期
An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of StroMel in subjects with moderate to severe OA of the kneee
研究概览
简要总结
The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 25-65 years
- •Body Mass Index (BMI) less than 40 kg/m2
- •Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry.
- •Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days
- •OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months
- •Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.
- •Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.
- •Have suitable knee joint anatomy for intra-articular injection.
- •For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
排除标准
- •Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- •Subject with an infection that requires parenteral antibiotic administration.
- •Active infection or crystal disease in the index joint within 1 month of screening
- •History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time
- •Intra-articular treatment of any joint with any of the following agents within 6 months of screening: Any corticosteroid preparation (investigational or marketed), sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection); investigational six months prior to enrollment.
- •Presence of surgical hardware or other foreign body in the index joint
- •Subjects who were administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening.
- •Planned or anticipated surgery of the joint during the study period
- •Allergies to anesthesia
- •Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or COVID-
- •Note: CMV is not a relevant communicable disease agent. A subject who tests positive or reactive for CMV is not necessarily ineligible. Physicians will determine donor eligibility for subjects with positive CMV test results.
- •History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.
- •Active cancer, chemotherapy, or other malignancies in the last 6 months.
- •Recent history of DVT or pulmonary embolism requiring anticoagulants or other medicines per the hematologist.
- •Subject who participated in another clinical trial within 3 months before the screening visit
- •Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- •Subjects who are breastfeeding
- •Subjects with uncontrolled arrhythmias
- •Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von Willebrand's disease.
研究组 & 干预措施
Subjects with moderate to severe OA of the Knee
Experimental
干预措施: StroMel (Biological)
结局指标
主要结局
Safety of StroMel in subjects with moderate to severe OA of the kneee
时间窗: 12 months
Presence of adverse events in less than 10% of the study population. Adverse events assessed will be Grade 4 administrative site infection, Grade 3 hypersensitivity/anaphylaxis, \>20% increase in WOMAC pain score, treatment-related disability, and presence of tumors post-treatment.
Overall Safety of StroMel
时间窗: 12 months
Summary of all study related AEs and SAEs.
次要结局
- Efficacy of StroMel in managing OA of the knee(52 weeks)
- Efficacy of StroMel in assessment of OA of the knee post-treatment(52 weeks)
研究者
研究点 (1)
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