ClinicalTrials.gg
RecruitingNCT07936162Updated Nov 13, 2026

Immune Reconstitution and Clinical Prognosis Following Umbilical Cord Blood Transplantation

An interventional study of Composite Immune Risk Score Stratification Notification Group in Transplant-Related Disorder, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Not applicable, Interventional, and Other

Updated Nov 13, 2026Newly registeredGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Transplant-Related Disorder
03

In context

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 413 studies on the registry; 292 are open to participants now.

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

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralComposite 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months post-transplant

  2. Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis

    Time frame: 6 months post-transplant

  3. Number of return visits

    Time frame: 6 months post-transplant

Secondary outcomes

  1. 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.

    Time frame: 1 year post-transplant

  2. Number of medication adjustments intended to accelerate immune reconstitution or enhance infection prophylaxis

    Time frame: 1 year post-transplant

  3. Number of return visits

    Time frame: 1 year post-transplant

  4. 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.

    Time frame: at 4, 6, 9 and 12 months post-transplant

  5. Infection rate

    Time frame: at 6, 9 and 12 months post-transplant

  6. Incidence of chronic GVHD

    Time frame: at 6, 9 and 12 months post-transplant

  7. Relapse rate

    Time frame: at 6, 9 and 12 months post-transplant

  8. Survival

    Time frame: at 6, 9 and 12 months post-transplant

  9. Hospitalization rate

    Time frame: at 6, 9 and 12 months post-transplant

  10. Outpatient rate

    Time frame: at 6, 9 and 12 months post-transplant

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    Tianjin, China
    Recruiting
    • Yahui Feng · Contact
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for May 2027, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 13, 2026
StartActual
Oct 16, 2026
Primary completionEst.
May 1, 2027
CompletionEst.
May 1, 2028
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936162
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Oct 16, 2026
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Nov 13, 2026

Study contacts

Yahui Feng
Contact
fengyahui@ihcams.ac.cn
022-23608045

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion