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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT06321198
• Date of registration: 13/03/2024
• Prospective Registration: No
• Primary sponsor: Anhui Provincial Hospital
• Public title: A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
• Scientific title: 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
• Date of first enrolment: February 10, 2024
• Target sample size: 12
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT06321198
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Xiaoyu Zhu, phd

• Name: Zhu Xiaoyu, Ph.D

• Name: Xiaoyu Zhu, PH.D
• Affiliation: Anhui Provincial Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 4 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Biological: iMSC

Primary Outcome(s)

Dose-Limiting Toxicity(DLT) [Time Frame: 4 weeks after initial infusion]

Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE) [Time Frame: From the date of initial infusion to 180 days after initial infusion]

Secondary Outcome(s)

Overall Survival(OS) [Time Frame: 100 days after initial infusion]

Objective Response Rate(ORR) [Time Frame: 28 days after initial infusion]

Secondary ID(s)

iMSC-2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors