EUCTR2017-001824-23-ES进行中（未招募）1 期
Intrathecal administration of autologous adult bone marrow mesenchymal stem cells expanded in the diffuse axonal injury.
Fundación de Investigación Biomédica del Hospital Universitario Puerta de Hierro-Majadahonda (FIBM-HUPHM)0 个研究点目标入组 10 人开始时间: 2017年9月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Traumatic brain injury background with cognitive effect and clinical diagnosis of diffuse axonal injury.
- •2) Clinical scale studies (GCS, NIF, ASHWORTH, GOAT, DRS) as well as neurophysiology and PET-TAC that would allow to have useful baseline values, with the purpose of being able to be compared with the same examinations after the study and obtain objective data of possible efficacy.
- •3) Aged between 18 and 70 years old.
- •4) Possibility of follow-up evolution and neuro-rehabilitation support during the follow-up period.
- •5) Written informed consent according to the current legislation.
- •6) Hematologic parameters and of creatinine, SGOT and SGPT within normal range according to the laboratory standards, accepting, nonetheless, modifications that are considered not significant in the context of the treatment to be carried out according to the clinical criteria of the research team.
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1) Age below 18 or over 70.
- •2) Pregnancy or lactation.
- •3) Patients with systemic disease that is considered by the research team to represent an added risk to the treatment.
- •4) Alterations in the performed genetic study to rule out risk of cell transformation in the expansion process.
- •5) Patients with doubts regarding their possible cooperation during the study.
- •6) Added neurodegenerative disease.
- •7) Current or past drug addiction or psychiatric disease, as well as current or past cancer disease that may interfere in the study to the investigators' opinion.
- •8) HIV Positive serology and/or syphillis or allergy to protein products used in the cell expansion process.
- •9) Active Hepatitis B or Hepatitis C, according to the serology analysis.
- •10) If in the opinion of the investigator there is some other cause for which the patient is not considered to be a candidate for the study.
研究者
相似试验
进行中（未招募）
1 期
Administration of bone marrow adult autologous mesenchymal cells expanded in chronically establish low injuries of the spinal cordEUCTR2017-000975-10-ESFundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda15
尚未招募
不适用
Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 StudyDiseases of the nervous systemKCT0000574Samsung Medical Center63
未知
4 期
Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)[Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injuryJPRN-jRCT1080220031DAIICHI SANKYO COMPANY, LIMITED
已完成
2 期
Evaluation of the effect of stem cell-mediated gene therapy in the treatment of glioblastomaIRCT20200502047277N3Shahid Beheshti University of Medical Sciences40
已完成
1 期
Evaluation of the safety and feasibility of stem cell-mediated gene therapy in the treatment of glioblastomaIRCT20200502047277N2Shahid Beheshti University of Medical Sciences8