Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06921980

Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia

Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior.

Brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

CAR T-cell Therapy Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Autoimmune Hemolytic Anemia Behavior Brain Function Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Xiao Yu, Undergraduate

CONTACT

[email protected]

18722218448

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of AIHA
  • Subjects will receive cell therapy such as CAR T-cell therapy
  • Male or female, aged 18-65 years
  • Willing and able to comply with the requirements for this study and written informed consent

Exclusion criteria

  • History of psychiatric illness
  • History of severe brain disease
  • Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study

Treatment and study plan

Brain function and psychological assessment

Other

Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

Primary outcomes

  1. Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.

  2. Psychological change

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    The Big Five Inventory-2(BFI-2) is used to measure the five broad dimensions of personality: openness, conscientiousness, extraversion, agreeableness, neuroticism. Higher scores indicate a stronger presence of that personality trait.

  3. Anxiety symptoms

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    Hamilton anxiety scale(HAMA) is used to examine anxiety in AIHA patients, with higher total scores indicate more severe anxiety symptoms. The total score range is 0-56.

  4. Depression symptoms

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    Hamilton depression scale(HAMD) is used to examine depression in AIHA patients, with higher total scores indicate more severe depression symptoms. The total score range is 0-52.

Secondary outcomes

  1. Sleep quality

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, with a higher global score indicating poorer sleep quality. The global score range is 0-21.

  2. Physical fatigue

    Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

    It measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The total possible score is 0-52 points, with higher scores indicating less fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Yu, Undergraduate

CONTACT

[email protected]

18722218448

Zhexiang Kuang, MSN

CONTACT

[email protected]

13920361752

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Tianjin University

Registry information

Official study title

Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.