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RecruitingNCT06321198Updated Mar 27, 2026

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

An interventional study of iMSC in Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD), sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Anhui Provincial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
4 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
03

In context

Lead sponsor

Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    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;

    Biological: iMSC

Interventions

  • BiologicaliMSC

    Subjects will receive 4 or more times of iMSC injection

06

What researchers measure

Primary outcomes

  1. Dose-Limiting Toxicity(DLT)

    Number of Dose-limiting toxicity in 28 days after injection

    Time frame: 4 weeks after initial infusion

  2. Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)

    Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0

    Time frame: From the date of initial infusion to 180 days after initial infusion

Secondary outcomes

  1. Objective Response Rate(ORR)

    Percentage of participants achieved Complete Response(CR) or Partial Response(PR)

    Time frame: 28 days after initial infusion

  2. Overall Survival(OS)

    The time from initial infusion to death

    Time frame: 100 days after initial infusion

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06321198
Lead sponsor
Anhui Provincial Hospital
Collaborators
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Responsible party
Xiaoyu Zhu (Chief physician, Anhui Provincial Hospital) — Principal investigator
First posted
Mar 20, 2024
Start date
Feb 10, 2024
Primary completion
Mar 2, 2027 (estimated)
Completion
Mar 2, 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Xiaoyu Zhu, phd
Contact
xiaoyuz@ustc.edu.cn
+86 15255456091
Xiaoyu Zhu, PH.D
principal investigator · Anhui Provincial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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