NL-OMON38437已完成不适用
A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution (APS) in Patients with Osteoarthritis (OA) of the Knee. - APSS-11-00
BioMet0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female >=40 years.
- •2. Body mass index (BMI) <=40 kg/m2.
- •3. A standing radiograph of the knee showing a Kellgren grade of 2 or 3 (within 6 months prior to screening or at screening).
- •4. Frequency of knee pain on most days (>15 days) over the last month.
- •5. Diagnosis of unilateral knee OA according to the American College of Rheumatology (ACR) criteria (clinical and radiological categories) based on an x ray performed within 6 months prior to screening.
- •7. On the WOMAC LK 3.1 questionnaire, the mean total score of the 5 pain subscale items together must be >=2.0 at screening and at baseline (Day 1 pre-injection).
- •8. Failed at least 1 conservative OA therapy (physiotherapy and/or simple analgesics)
排除标准
- •1. On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
- •2. Diagnosed with rheumatoid arthritis (RA), Reiter*s syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis).
- •3. Arthritis of metabolic origin.
- •4. Ipsilateral hip OA.
- •5. Untreated traumatic injury of knee.
- •6. Limited daily activity for reasons other than OA.
- •7. Presence of surgical hardware or other foreign body in the knee.;Prior or concomitant OA treatment-related criteria:
- •8. Arthroscopy or open surgery in knee within12 months prior to screening.
- •9. Intra-articular steroid injections in any joint within 3 months prior to screening.
- •10. Intra-articular hyaluronic acid (HA) in any joint within 6 months prior to screening.
- •11. Other intra-articular therapy in any joint within 3 months prior to screening.
- •12. Taking systemic steroids within 2 weeks prior to screening.
- •13. Planned/anticipated surgery of the knee during the study period.;Patient-related criteria:
- •14. Any clinically significant results at screening (values or findings outside of normal ranges that are deemed clinically significant by the investigator).
- •15. Active or history of malignancy other than non-melanoma skin cancer.
- •16. Any serious, non-malignant, significant, acute, or chronic medical condition (e.g., diabetes, cardiopathy) or active psychiatric illness that, in the investigator*s opinion, could compromise patient safety, limit the patient*s ability to complete the study, and/or compromise the objectives of the study.
- •17. Skin breakdown at the knee where the injection is planned to take place.
- •18. Pregnant or nursing mothers, or women likely to conceive a child and unwilling to use a reliable form of birth control for the duration of the study.
- •19. History of drug or alcohol dependence and/or positive screening results from urine drug and alcohol tests.
- •20. Used any investigational drug or device within 30 days prior to screening, or 5 half-lives, whichever is longer.
- •21. Used any investigational biologic within 60 days prior to screening.
研究者
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