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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALiMSC

Subjects will receive 4 or more times of iMSC injection


Locations(1)

Anhui Provincial Hospital

Hefei, Anhui, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06321198