NL-OMON40295已完成不适用
Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients - MSCs therapy in renal recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Female or male, aged between 18 and 75 years.
- •2.Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
- •3.Recipients of a first kidney graft from a living-unrelated or non-HLA identical living related donor.
- •4.Panel Reactive Antibodies (PRA) <= 50%.
- •5.Patients must be able to adhere to the study visit schedule and protocol requirements.
- •6.If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
排除标准
- •1. Double organ transplant recipient.
- •2. Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks before MSC infusion.
- •3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.
- •4. Patients suffering from hepatic failure.
- •5. Patients suffering from an active autoimmune disease.
- •6. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- •7. Use of any investigational drug after transplantation.
- •8. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
- •9. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.
- •10. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria.
- •11. Known recent substance abuse (drug or alcohol).
- •12. Patients who are recipients of ABO incompatible transplants.
- •13. Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (lipid lowering treatment with controlled hyperlipidemia is acceptable).*
研究者
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