RecruitingNot Applicable

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

China12 participantsStarted 2024-02-10

Plain-language summary

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

Age range4 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓.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;

✕. 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;

Dose-Limiting Toxicity(DLT)

Timeframe: 4 weeks after initial infusion

Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)

Timeframe: From the date of initial infusion to 180 days after initial infusion

NCT IDNCT06321198

SponsorAnhui Provincial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-03-02

Xiaoyu Zhu, phd

Who can participate

Age range4 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓.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;

✕. 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;