NL-OMON53310尚未招募不适用
Safety and Efficacy of MCA-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients: The Nereid Study* - MCA-derived MSC therapy in renal transplant recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
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.
- •If a donor is > 50 years of age, recipient must be >25 years of age.
- •4. Panel Reactive Antibodies (PRA) <= 10%.
- •5. No HLA repeated mismatch between MCA-derived MSC and the HLA mismatch
- •between kidney graft and recipient.
- •6. Patients must be able to adhere to the study visit schedule and protocol
- •requirements.
- •7. 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 first
- •6 weeks after
- •transplantation.
- •3. Patients with evidence of active infection or abscesses (with the exception
- •uncomplicated urinary tract infection) before MSC infusion.
- •4. Patients suffering from hepatic failure.
- •5. Patients suffering from an active autoimmune disease.
- •6. Patients who have had a previous BM transplant.
- •7. A psychiatric, addictive or any disorder that compromises ability to give
- •truly informed
- •consent for participation in this study.
- •8. Use of any investigational drug after transplantation.
- •9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to
- •current transplantation inclusion criteria.
- •10. Subjects who currently have an active opportunistic infection at the time
- •of MCA-derived MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus
- •(CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or
- •mycobacteria other than TB, BK) after transplantation.
- •11. 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.
- •12. Known recent substance abuse (drug or alcohol).
- •13. Patients who are recipients of ABO incompatible transplants.
- •14. Cold ischemia time >30 hrs.
- •15.Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total
- •hypertriglyceridemia (>5.6 mmol/L) (patients on lipid lowering treatment with
- •controlled hyperlipidemia are acceptable).
- •16. Repeated HLA mismatch present between the MCA-derived MSC and the
- •mismatches between donor and kidney graft
研究者
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