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Clinical Trials in China / NCT06321198
Recruiting Not applicable

A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD

NCT06321198 · tracked via the Priya Life Science China tracker
Sponsor
Anhui Provincial Hospital
Phase
Not applicable
Started
2024-02-10
Last updated
2026-03-27

Condition(s) studied

Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)

Investigational drug(s) / intervention(s)

iMSC

iMSC: Subjects will receive 4 or more times of iMSC injection

Study summary

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

Eligibility

Sex
ALL
Min age
4 Years
Max age
70 Years
Healthy volunteers
No
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 enrollment; 9. Have active thrombus; 10. Have untreated or uncertain active solid tumors within 5 years; 11. 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; 12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive; 13. Have active hepatitis B or hepatitis C; 14. Have gastrointestinal symptoms which not caused by GVHD 15. 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; 16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening; 17. Not suitable for this clinical trial for other reasons.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Recruiting

More Anhui Provincial Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06321198 on ClinicalTrials.gov ↗ ← All trials in China