Evaluaing the safety and effectiveness of intravenous infusion of placenta-derived mesenchymal stem cells and placenta-derived mesenchymal stem cell exosomes in steroid-resistant acute GvHD patients; Phase I and II clinical trial

Tehran University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Acute aGvHD grade II-IV according to MAGIC criteria and steroid resistant according to EBMT-NIH-CIBMTR
•A patient who underwent allogeneic HSCT with the following conditions: HLA-matched donor (MRD), HLA-mismatched donor (MUD), unrelated cord blood (UCB), haploidal donor

•Positive serology for hepatitis B, hepatitis C and AIDS virus or fungal infection
•Patients with penicillin and/or gentamicin allergy or known allergy to cow or pork products
•Participants with uncontrolled diseases including persistent or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or specific social situations that limit compliance with study requirements
•Any condition that, in the investigator's judgment, interferes with full participation in the study, including the administration of study medication or participation in required study visits, or poses a significant risk to the participant, or interferes with the interpretation of study data
•Transplant recipient for solid tumor
•Diagnosis of Sinus Obstructive Syndrome (SOS) or Venous Obstructive Disease, at any time of study with appropriate tests
•Pregnancy and breastfeeding

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