NCT06321198 A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
| NCT ID | NCT06321198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-02-10 |
| Primary Completion | 2027-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2024-02-10 with a primary completion date of 2027-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Eligibility 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.
Contact & Investigator
Xiaoyu Zhu, PH.D
PRINCIPAL INVESTIGATOR
Anhui Provincial Hospital
Frequently Asked Questions
Who can join the NCT06321198 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 70 Years, studying Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321198 currently recruiting?
Yes, NCT06321198 is actively recruiting participants. Contact the research team at xiaoyuz@ustc.edu.cn for enrollment information.
Where is the NCT06321198 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06321198 clinical trial?
NCT06321198 is sponsored by Anhui Provincial Hospital. The principal investigator is Xiaoyu Zhu, PH.D at Anhui Provincial Hospital. The trial plans to enroll 12 participants.