RecruitingNot ApplicableNCT06321198
A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease
Sponsor
Anhui Provincial Hospital
Enrollment
12 participants
Start Date
Feb 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Eligibility
Min Age: 4 YearsMax Age: 70 Years
Inclusion Criteria1
- 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 Criteria17
- Accepted systemic or local treatment of mesenchymal stem cells;
- Have severe allergy to blood products or have allergy history of heterologous protein;
- Expected survival period within 3 months;
- 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);
- Have severe hepatic veno-occlusive disease(HVOD);
- Have severe lung disease like severe lung infection;
- Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;
- Proved having resistant hypertension within 6 months before enrollment;
- Have active thrombus;
- Have untreated or uncertain active solid tumors within 5 years;
- Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
- Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;
- Have active hepatitis B or hepatitis C;
- Have gastrointestinal symptoms which not caused by GVHD
- Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;
- Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;
- Not suitable for this clinical trial for other reasons.
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Interventions
BIOLOGICALiMSC
Subjects will receive 4 or more times of iMSC injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06321198