Actively Recruiting

Phase Not Applicable
Age: 4Years - 70Years
All Genders
NCT06321198

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

Led by Anhui Provincial Hospital · Updated on 2026-03-27

12

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

A

Anhui Provincial Hospital

Lead Sponsor

I

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects who understand and voluntarily sign the Informed Consent Form (ICF)
  • Age between 4 and 70 years
  • Diagnosed with steroid-refractory acute graft-versus-host disease (SR-aGVHD)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Have II to IV grades of steroid hormone resistance
Not Eligible

You will not qualify if you...

  • Previous systemic or local treatment with mesenchymal stem cells
  • Severe allergy to blood products or history of allergy to heterologous proteins
  • Expected survival period of less than 3 months
  • Alanine transaminase (ALT) or Aspartate aminotransferase (AST) levels greater than twice the upper limit of normal (ULN)
  • Creatinine clearance rate less than or equal to 30 ml/min or Blood Urea Nitrogen (BUN) greater than twice ULN
  • International Normalized Ratio (INR) greater than 1.5 times ULN
  • Severe hepatic veno-occlusive disease (HVOD)
  • Severe lung disease such as severe lung infection
  • History of severe acute myocardial infarction, uncontrolled angina pectoris, arrhythmia, or severe heart failure
  • Resistant hypertension within 6 months before enrollment
  • Active thrombus
  • Untreated or uncertain active solid tumors within 5 years
  • Alcohol or drug addiction, history of mental disorders, or use of psychotropic substances
  • Positive for human immunodeficiency virus (HIV) antibody or treponema pallidum (TP) antibody
  • Active hepatitis B or hepatitis C
  • Gastrointestinal symptoms not caused by graft-versus-host disease
  • Pregnant or lactating females or inability to comply with contraceptive requirements during the study and for 6 months after
  • Participation in other clinical trials with use of investigational products within 12 weeks before screening
  • Any other reason deemed unsuitable for this clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Anhui Provincial Hospital

Hefei, Anhui, China, 230036

Actively Recruiting

Loading map...

Research Team

X

Xiaoyu Zhu, phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here