ACTRN12615001260516终止2 期
A randomised, placebo-controlled, double-blind, proof of concept study of the safety and efficacy of autologous stromal vascular fraction (SVF) cells, in patients with moderate to severe chronic migraine headache
Cell-Innovations0 个研究点目标入组 4 人开始时间: 2015年11月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Chronic migraine (satisfying the International Classification of Headache Disorders (ICHD-2R) criteria). The ICHD-2R defines chronic migraine as more than fifteen headache days per month over a three month period of which more than eight are migrainous, in the absence of medication over use.
排除标准
- •1. Participants who have received investigational agents within 4 weeks (or 5 half-lives) of treatment.
- •2. Subjects with significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of the study.
- •3. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.
- •4. Participants who have had active neoplastic disease (cancer) in the previous 3 years.
- •5. Presence of active infection (except for colds or minor URTI). History of human immunodeficiency virus or acquired immune deficiency syndrome. Significant peripheral vascular disease.
- •6. Participants who are pregnant or lactating. Female participants who have positive serum beta HCG pregnancy test taken within 7 days before treatment.
- •7. Fertile participants who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
- •8. Previous treatment with SVF.
- •9. Conditions/therapies/factors which could confound or interfere with the evaluation of pain including but not limited to:
- •a) Treatments with strong opioid drugs in the previous 60 days for pain
- •b) Procedures planned during the study period which could interfere with pain assessment (e.g. surgery)
- •c) Other causes of chronic pain (e.g. neck pain)
- •10. Use of anticoagulant medication
- •11. Consistent use of NSAIDs within 48 hours of procedure.
- •12. Aspirin (except at low dose for cardioprotection), Vitamin E, Fish Oil, krill oil or anti-inflammatories for one week prior
- •13. Insufficient fat present for liposuction.
- •14. Inability to understand the study or complete headache diary/ SF-36 questionnaires.
- •15. Allergic to dimethyl sulfoxide (DMSO)
- •16. Inability to provide informed consent
研究者
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