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Study on aGVHD biomarkers and immune reconstitution in recipients undergoing allogeneic hematopoietic stem cell transplantation

Study on aGVHD biomarkers and immune reconstitution in recipients undergoing allogeneic hematopoietic stem cell transplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118360
Enrollment
Unknown
Registered
2026-02-04
Start date
2023-09-15
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematopoietic stem cell transplantation

Interventions

?~? acute graft·versus-host disease group:None
0~I acute graft·versus-host disease group:None
Normal control group:None

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 60 Years

Inclusion criteria

Inclusion criteria: Case group: 1. Age range from 14 to 60 years old, regardless of gender; 2. Patients with hematological disorders undergoing allogeneic hematopoietic stem cell transplantation; 3. The subjects voluntarily participate in the trial and sign the informed consent form, and the process of signing the informed consent form meets the requirements of GCP. Healthy controls: 1. Participants of both sexes, aged 14-60 years, who underwent physical examination during the same period; 2, no past medical history and genetic history, confirmed as a healthy person by physical examination.

Exclusion criteria

Exclusion criteria: Case group: 1. Individuals with severe cardiac insufficiency and a heart ejection fraction EF below 60%; or severe arrhythmia, or intolerant to strong preconditioning evaluated by researchers; 2. Patients with severe pulmonary insufficiency (obstructive and/or restrictive ventilation disorders) who cannot tolerate the preconditioning regimen as evaluated by the researchers; 3. Severe liver dysfunction accompanied by liver function indicators (ALT, TBIL) exceeding the upper limit of normal values (ULN) by more than 3 times; Researchers evaluate individuals who cannot tolerate strong preconditioning regimens; 4. Accompanied by severe renal insufficiency, the renal function index (Cr) is more than twice the upper limit of normal (ULN); or if the 24-hour urinary creatinine clearance rate (Ccr) is less than 50ml/min, and the researcher evaluates that they cannot tolerate the super strong pre-treatment regimen; 5. Severe active infection before transplantation, evaluated by researchers as unable to tolerate preconditioning beyond tolerance; 6. Individuals who have experienced allergic reactions or serious adverse reactions during previous use of preconditioning related drugs and have been evaluated as ineligible by the researchers; 7. Other reasons for not being included in the researcher's evaluation. 8. The researcher determined that the participants were not suitable for this experiment. Healthy controls: Exclusion criteria were those who were deemed by the investigators to be unfit for the trial.

Design outcomes

Primary

MeasureTime frame
Bile acid of Intestinal metabolites;Cytokine;Mononuclear cells;

Secondary

MeasureTime frame
Microbiota;Biomarkers;

Countries

China

Contacts

Public ContactLijie Han

The First Affiliated Hospital of Zhengzhou University

hanlijiede@126.com+86 187 0380 9807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026