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

NCT ID: NCT06321198

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2027-03-02

Brief Summary

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

Detailed Description

A single center, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iMSC injection

Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week;

Group Type: EXPERIMENTAL

iMSC

Intervention Type: BIOLOGICAL

Subjects will receive 4 or more times of iMSC injection

Interventions

iMSC

Subjects will receive 4 or more times of iMSC injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Zhu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyu Zhu, PH.D

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Hospital

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyu Zhu, phd

Role: CONTACT

xiaoyuz@ustc.edu.cn

+86 15255456091

Facility Contacts

Zhu Xiaoyu, Ph.D

Role: primary

xiaoyuz@ustc.edu.cn

+86 15255456091

Sun Guangyu

Role: backup

sunguangyu_vip@foxmail.com

+86 13956970687

Other Identifiers

iMSC-2001

Identifier Type: -

Identifier Source: org_study_id