CTIS2023-510228-63-00进行中（未招募）1 期
Study of Mesenchymal Autologous stem cells as Regenerative Treatment for Multiple Sclerosis (SMART-MS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Age =18 to =55, both genders, Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS, An EDSS score of 4 to 7, Disease duration 2 - 18 years, Signed, written informed consent
排除标准
- •Treatment with cytotoxic medications during the last 3 months prior to inclusion, History of malignancy, other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year within the last 10 years, Severely limited life expectancy by another co-morbid illness, History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts, Immunocompromised patients, Estimated glomerular filtration rate <60 ml/min/1.73 m2 or known renal failure, Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment, Platelet (thrombocyte) count <100 x 10*9/L, Participation in another experimental clinical study with administration of another IMP within the preceding 12 months, Contraindications to MRI, Prior or current major depression, Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment, Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol., Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation, Known hypersensitivity against paracetamol, codein or xylocain, Diagnosis or strong suspicion of polyneuropathy, Prior or current alcohol or drug dependencies, Inability to give informed consent, Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity, Current immunomodulatory/immunosuppressive treatment, Immunomodulatory/immunosuppressive treatment within 6 months prior to inclusion. This includes, but is not restricted to treatment with natalizumab, fingolimod, dimetylfumurat, glatiramer acetate, interferon beta medications, teriflunomide, and siponimod., Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion, Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion, Treatment with glucocorticoids or ACTH within three months prior to start of inclusion, Having experienced an MS relapse within 2 years prior to study inclusion
研究者
相似试验
尚未招募
2 期
SMART-MSMultiple sclerosis2023-510228-63-00Helse Bergen HF18
已完成
早期 1 期
Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathydiabetic retinopathy (dibetes type one).H36.0*Diabetic retinopathyIRCT201111291414N29The EMRI Endocrinology and Metabolism Research Institute ? Tehran University of Medical Sciences20
已完成
2 期
Effect of mesenchymal stem cells transplantation to improve of diabetic neuropathyDiabetic neurophaty.Diabetic polyneuropathy (E10-E14 with common fourth character .4+)G63.2*IRCT201103171414N23???Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences20
已完成
早期 1 期
Investigation on autologous mesenchymal stem cell transplantation in diabetic nephrophaty (type one)Diabetes Nephropathy (type 1).Glomerular disorders in diabetes mellitusIRCT201111291414N28Endocrinology and Metabolism Research Institute (EMRI)20
进行中（未招募）
不适用
Bone marrow cell treatment as treatment of multiple sclerosisMedDRA version: 16.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple SclerosisEUCTR2012-000734-19-ESBanc de Sang i Teixits