EUCTR2015-002383-16-ES进行中（未招募）1 期
Evaluate the efficacy of the cell therapy with NC1 medication in patients with post-traumatic syringomyelia
Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro0 个研究点目标入组 6 人开始时间: 2015年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Post-traumatic spinal cord injury patients (Level A, B, C or D in ASIA scales), with associated syringomyelia extended at least in three vertebral segments, and neurological stable clinic for at least 6 months prior to study start.
- •2.Previous studies of Neurophysiology, MRI and Urology (if neurogenic bladder data exist) and defecatory activity (if neurogenic intestine signs exist) to allow useful baseline, in order that they can be compared with the same scans at the end of the follow uo period, and to obtain objective data of potential efficacy.
- •3.Age between 18 and 70 years.
- •4.Neuroimagin (MR) that allow to confirm the syringomyelic cavity existence extended at lest 3 vertebral segments.
- •5.Men and women of childbearing age must compromisse to use contraceptives from the time at which the removal of cells from the bone marrow is performed until 6 months after the celular administration.
- •6.Possibility of follow up and commitment to perform ambulatory physical therapy, at least one hour per day, five days per week, throughout all treatment period.
- •7.Written informed consent, according to the law in force.
- •8.Hematologic, creatinine, SGOT and SGPT parameters, within the normal range, according to laboratory standards. However, slight modifications that are considered significant in the context of treatment to be performed, according to the criterion of the research team, are accepted.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Age below 18 years or above 70.
- •2. Pregnancy or lactation.
- •3. Current neoplastic disease or in the previous 5 years (diagnosed or treated).
- •4. Patients with systemic disease or other pathology that represents an added risk to the cellular therapy treatment or to the surgical operation.
- •5. Alterations in the genetic study performed to discard risk cell transformation in the expansion process.
- •6. Patients with doubts about possible cooperation in the maintenance physical therapy or in the controls carried out during the study
- •7. Neurodegenerative disease added.
- •8. History of substance abuse, psychiatric disease or allergy to protein products used in the process of cell expansion.
- •9. Positive serology for HIV and syphilis.
- •10. Active Hepatitis B or Hepatitis C, according to serology analysis.
- •11. If in the opinion of the researcher there is some other reason why the patient is not considered candidate for the study.
研究者
相似试验
已完成
2 期
Efficacy Assessment of the Cell Therapy Medicine NC1 in Patients With Post-traumatic SyringomyeliaPost-Traumatic SyringomyeliaNCT02807142Puerta de Hierro University Hospital6
进行中（未招募）
1 期
Development of cell therapy for Salivary gland regeneratioJPRN-jRCTb070190057Asahina Izumi6
招募中
1 期
Treatment of ocular chemical burns with cellular fibrin membraneIRCT20140911019125N9Kerman University of Medical Sciences15
已完成
2 期
A Phase II trial of cellular immunotherapy on CA-125 response with M-FP cancer vaccine in patients with epithelial ovarian carcinomaCancer - Ovarian and primary peritonealOvarian CancerACTRN12605000442606Cancer Vac Pty Ltd20
尚未招募
不适用
Cellular therapy in patients with cancer undergoing bone marrow transplantatioCTRI/2021/03/032020WellcomeDBT India Alliance