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Tests treatment safety and results for Steroid-refractory Acute Graft-versus-host...
Official title A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
ClinicalTrials.gov ID: NCT06321198
What this study is testing
What is iMSC?
iMSC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for steroid-refractory acute graft-versus-host disease(sr-agvhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 70
You may be able to join if
- 1.people who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.people with SR-aGVHD; 4.ECOG≤2; 5.people with II to IV...
You likely can't join if
- 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...
- Have severe hepatic veno-occlusive disease(HVOD);
- Have severe lung disease like severe lung infection;
See the full eligibility criteria
- 1.people who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.people with SR-aGVHD; 4.ECOG≤2; 5.people 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...
- 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 people, or people who are unable to comply with contraceptives from the study period to 6 months after the end of this study;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.