Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06921980

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-05

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Institute of Hematology & Blood Diseases Hospital, China

Lead Sponsor

T

Tianjin University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of cell therapy on brain function and psychological well-being in patients with autoimmune hemolytic anemia (AIHA). This observational study aims to detect any cognitive or behavioral changes that may occur due to cell therapy, such as CAR T-cell therapy, to help develop safer and more effective treatment methods and improve patients' quality of life. Participants will undergo brain function and psychological assessments before receiving cell therapy and then again on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. These assessments will monitor changes in oxygenated and de-oxygenated hemoglobin levels, psychological status, anxiety, depression symptoms, sleep quality, and physical fatigue throughout the study period. During the study, patients will regularly complete evaluations measuring brain oxygen levels and various psychological and physical symptoms at multiple time points. This close monitoring helps detect any changes early, allowing timely interventions. The study is conducted by the Institute of Hematology & Blood Diseases Hospital, and participation lasts for at least 28 days following cell therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of autoimmune hemolytic anemia (AIHA)
  • Receiving cell therapy such as CAR T-cell therapy
  • Male or female participants aged 18 to 65 years
  • Willing and able to follow study requirements and provide written informed consent
Not Eligible

You will not qualify if you...

  • History of psychiatric illness
  • History of severe brain disease
  • Any other reason the investigator believes makes participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 4 weeks

Participants undergo brain function and psychological assessments before cell therapy and multiple times up to 28 days after treatment to monitor changes related to the therapy.

8 visits (including baseline before treatment and Days 1, 4, 7, 10, 14, 21, and 28 after treatment)

Trial Site Locations

Total: 1 location

1

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Actively Recruiting

Loading map...

Research Team

Z

Zhexiang Kuang, MSN

X

Xiao Yu, Undergraduate

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

More Than Cerebral Cortex: 7T Anatomical and Functional Stud...

Brain Function

Actively Recruiting

2 locations

A Phase 1/2 Clinical Study of CM336 Injection in Patients Wi...

Autoimmune Cytopenia

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here