NCT04826224终止1 期
A Pilot Study For The Use Of Human Autologous Bone Marrow Aspirate Concentrate (BMAC) Combined With Arthroscopic Surgery For Painful Shoulder Osteoarthritis
Shane A. Shapiro1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年12月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Morbidity related to bone marrow aspirations from iliac crests
研究概览
简要总结
Researchers want to find out more about the side effects of Bone Marrow Aspirate Concentrate (BMAC) and what doses of BMAC are safe for people.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects.
- •Subjects must be 50 years of age or older.
- •Subjects must have OA in a single or bilateral shoulder(s) with an inferior osteophyte measuring <7 mm.
- •> 1 mm joint space width in the study shoulder.
- •ASES score of 14.1 to 88.5
- •Osteoarthritis must be primary. Subjects must have previously tried 6 months of one of the following conservative treatments: activity modification, physical therapy, and anti-inflammatory or injection therapy.
- •Patients can provide written informed consent after the nature of the study is fully explained.
排除标准
- •Patients with clinically significant abnormal hematology, serum chemistry, or urinalysis screening laboratory results. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered non-exclusionary. If repeat non-clinically relevant, non-life-threatening results do not normalize the patient may be further evaluated by a specialist or primary care provider to determine if lab result should be exclusionary.
- •Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
- •Walch Type B2/C glenoid.
- •Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
- •Patients receiving injections to the treated shoulder within 3 months prior to study entry,
- •Patients who are pregnant or currently breast-feeding children. Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 3 months following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
- •Patients with systemic, rheumatic or inflammatory disease of the shoulder or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the shoulder associated with juxta-articular Paget's disease, ochronosis, hemophilic arthropathy, infectious arthritis, villonodular synovitis, and synovial chondromatosis.
- •Patients with ongoing infectious disease, including HIV and hepatitis.
- •Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes.
- •Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
- •Patients with hardware or implants in the affected shoulder.
- •Patients with previous open shoulder surgery or an arthroscopic procedure requiring structural repair with anchors and/or sutures.
- •Presence of large glenoid cysts
- •Opiate use within three months.
- •Patients taking Coumadin or Plavix
研究组 & 干预措施
Subjects with Osteoarthritis of the shoulders
Experimental
Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
干预措施: Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. (Biological)
结局指标
主要结局
Morbidity related to bone marrow aspirations from iliac crests
时间窗: 1-3 Weeks Post-Procedure
Occurrence of adverse reactions to bone marrow aspirations from iliac crests
Adverse Reactions
时间窗: 1-3 Weeks Post-Procedure
Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure
次要结局
- Change in range of motion(Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery)
- Change in Visual Analog Scale (VAS)(Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery)
- Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)(Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery.)
- Change in Subjective Shoulder Value(Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery)
- To collect and explore pre and post injection measures of cartilage status in the affected shoulder.(12 Months)
研究者
Shane A. Shapiro
Regulatory Sponsor
Mayo Clinic
研究点 (1)
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