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

Recruiting

• Conditions: Psychological Well-Being; CAR T-cell Therapy; Autoimmune Hemolytic Anemia; Brain Function

• Registration Number: NCT06921980
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-25
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)	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.
Psychological change	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.
Anxiety symptoms	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.
Depression symptoms	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 Outcome Measures

Name	Time	Method
Physical fatigue	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.
Sleep quality	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.

Trial Locations

Locations (1)

Regenerative Medicine Center; 🇨🇳 Tianjin, Tianjin, China