NCT06321198 A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
| NCT ID | NCT06321198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-02-10 |
| Primary Completion | 2027-03-02 |
Trial Parameters
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Brief Summary
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Eligibility Criteria
Inclusion Criteria: 1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance; Exclusion Criteria: 1. Accepted systemic or local treatment of mesenchymal stem cells; 2. Have severe allergy to blood products or have allergy history of heterologous protein; 3. Expected survival period within 3 months; 4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\>2\*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)\>2\*upper limit of normal(ULN), International Normalized Ratio (INR)\>1.5\*upper limit of normal(ULN); 5. Have severe hepatic veno-occlusive disease(HVOD); 6. Have severe lung disease like severe lung infection; 7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure; 8. Proved having resistant hypertension within 6 months before enroll