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| Name | Class |
|---|---|
| Tianjin University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Brain function and psychological changes in AIHA patients will be monitored throughout cell therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR) | Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations. | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| Psychological change | 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. | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| Anxiety symptoms | 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. | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| Depression symptoms | 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. | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | 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. | Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| Physical fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed/refractory AIHA who will receive cell therapy, such as CAR T-cell therapy, from 2025 to 2026.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhexiang Kuang, MSN | Contact | 13920361752 | kuangzhexiang@ihcams.ac.cn | |
| Xiao Yu, Undergraduate | Contact | 18722218448 | yuxiao@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenerative Medicine Center | Recruiting | Tianjin | Tianjin Municipality | China |
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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. |
| Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. |
| ID | Term |
|---|---|
| D000744 | Anemia, Hemolytic, Autoimmune |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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