EUCTR2015-005717-80-ES进行中（未招募）1 期
Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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.Male or female subjects ? 18 to ? 65 years.
- •3. Spinal Injury with neurological level between D5?D10 (cohorts 1 and 2)
- •4.Single traumatic spinal cord injury as defined by MRI.
- •5. Injury occurred between 72 and 120 h before undergoing DSS and treatment.
- •6.Clinically and haemodynamically stable enough to undergo DSS.
- •7.Able to give informed consent either in writing or verbally in the presence of a witness.
- •1. Male or female subjects ? 18 to ? 65 years.
- •2. ASIA A or B.
- •3. Spinal Injury with neurological level between (D1?D12) (D12 without ZPPM).
- •4.Single traumatic spinal cord injury as defined by MRI.
- •5. Injury occurring between 24 and 72h before undergoing DSS and treatment.
- •6.Clinically and hemodynamically stable enough to undergo DSS.
- •7.Able to give informed consent either in writing or verbally in the presence of a witness.
- •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 46
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Participation in any clinical investigation within 28 days prior to spinal cord injury or if a cell therapy product has been administrated in the previous five years of SCI
- •2.MRI or DSS evidence of complete spinal cord transection or equivalent severe lesion or abnormality.
- •3.Inability to unequivocally identify the injection sites.
- •4.Multiple injuries to the neurological spinal cord at different levels.
- •5.Patients with any of these additional conditions:
- •a.Penetrating spinal cord injuries.
- •b.Associated trauma or injury to the brachial and / or lumbosacral plexus.
- •6.Active infection in the surgical area.
- •Surgical risk and clinical condition
- •7.Haemodynamic instability contraindicating DSS procedure in the time frame defined for inclusion in the trial.
- •8.Multiple organ failure.
- •Neurological
- •9.Significant head injury (Score on the Glasgow scale less than or equal to 13 and / or abnormal MRI/CT) or other injury that, in the investigator's opinion, is sufficient to interfere with the assessment of spinal cord function or compromise the validity of patient data.
- •10.Patients undergoing mechanical ventilation that does not allow a prior clinical examination.
- •11.Inability to communicate with the neurological examiner, so that the validity of patient data could be unreliable.
- •12.Patients who are unconscious, including those unconscious to require sedative-analgesic medications.
- •Basal condition and personal clinical history
- •13.Preexisting or current significant diseases such as hepatitis C, HIV, epilepsy, neoplastic disease or other diseases that could cause neurological deficits, including syphilis, myelopathy, and polyneuropathy.
- •14. Background or acute episode of Guillain?Barre syndrome.
- •15. History of meningitis or meningoencephalitis.
- •16. Current history of autoimmune disease.
- •17.Patients with uncontrolled blood diathesis or under anticoagulant or antiplatelet pharmacological therapy.
- •18.Presence of any psychiatric illness, as defined by the DSM-IV-TR, or medically unstable illness which can reasonably be expected to pose an increased risk to on participating in the study, or which causes a significant deterioration of the clinical course of the patient. Secondary depression is expressly excluded.
- •19. Drug abuse as defined by DSM-IV-TR during the 6 months prior to SCI.
- •20. Pregnant women.
- •21. Women who are breastfeeding if unwilling to stop at the time of recruitment.
- •22. History of life-threatening allergy or immune reaction.
- •23. Patients with known hypersensitivity to any of the excipients of FAB117-HC.
- •24. Patients with known or suspected hypersensitivity.to bovine serum, enzymes (trypsin, collagenase type I / II), penicillin, streptomycin or DMSO
研究者
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