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

Who can participate

Age range

4 Years – 70 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

.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

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06321198

SponsorAnhui Provincial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-03-02

Contact for this trial

Xiaoyu Zhu, phd

+86 15255456091 xiaoyuz@ustc.edu.cn

View on ClinicalTrials.gov More Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD) trials