Immune Reconstitution and Clinical Prognosis Following Umbilical Cord Blood Transplantation

A Prospective Study on Immune Reconstitution and Clinical Prognosis in Patients After Umbilical Cord Blood Transplantation

In this prospective randomized controlled trial of umbilical cord blood hematopoietic stem cell transplant recipients, post-transplant immune data will be collected from two groups. A composite immune risk score will be used to assess immune reconstitution for risk stratification and analyze its associations with clinical prognostic endpoints.

Study Overview

• Status: Recruiting
• Conditions: Transplant-Related Disorder
• Intervention / Treatment: Behavioral: Composite Immune Risk Score Stratification Notification Group

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yahui Feng; Phone Number: 022-23608045; Email: fengyahui@ihcams.ac.cn

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    • Contact: Yahui Feng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 14 years old
2. Umbilical cord blood transplant
3. Patients must provide written informed consent before the start of the study procedures.

Exclusion Criteria:

1. Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
2. Death or loss to follow-up of the patient prior to immune reconstitution stratification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Composite Immune Risk Score Stratification Notification Group; Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring.	Behavioral: Composite Immune Risk Score Stratification Notification Group; Attending physicians will receive immune reconstitution risk stratification results of patients calculated by the composite immune risk score model to guide patient health monitoring.
No Intervention: Standard Care Control Group; No risk stratification results of patients from the composite immune risk score model will be provided to attending physicians. Patients receive standard routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)	Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 6 months after umbilical cord blood transplantation. Test counts are extracted from electronic medical records.	6 months post-transplant
Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis		6 months post-transplant
Number of return visits		6 months post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of infection-related laboratory testing (blood culture, pathogen PCR, NGS)	Defined as the count of infection-related laboratory tests (blood culture, pathogen PCR, pathogen NGS) for each patient within 1 year after umbilical cord blood transplantation. Test counts are extracted from electronic medical records.	1 year post-transplant
Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis		1 year post-transplant
Number of return visits		1 year post-transplant
Immune reconstitution status (quantity of T, B, NK cells and other immune subsets, and T cell clonal diversity)	Defined as the quantity of T cells, B cells, NK cells and other immune subsets measured by flow cytometry, and T cell clonal diversity assessed by TCR repertoire sequencing at scheduled time points. Data are extracted from electronic medical records.	at 4, 6, 9 and 12 months post-transplant
Infection rate		at 6, 9 and 12 months post-transplant
Incidence of chronic GVHD		at 6, 9 and 12 months post-transplant
Relapse rate		at 6, 9 and 12 months post-transplant
Survival		at 6, 9 and 12 months post-transplant
Hospitalization rate		at 6, 9 and 12 months post-transplant
Outpatient rate		at 6, 9 and 12 months post-transplant

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 11, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 11, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SKIRT-CB-RCT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No