Unexpected Seizure Complication Post-Apheresis in Sickle Cell Disease Patient Highlights Need for Adverse Event Reporting

Strategic Insights -

A recent study published in the Journal of Clinical Apheresis has highlighted the need for reporting and collecting all adverse events that occur during or after apheresis procedures in patients with sickle cell disease undergoing gene therapy. The case report details a previously unreported grade 4 adverse event in a 23-year-old male patient who experienced a generalized tonic-clonic seizure after autologous stem cell collection for gene therapy.

The patient, who had been undergoing gene therapy for sickle cell disease, experienced a seizure about 8 hours after the stem cell collection procedure. Imaging revealed a right temporal infarct, and common causes such as electrolyte imbalance, thromboembolic event, and posterior reversible encephalopathy syndrome (PRES) were excluded. The research concluded that the seizure may have been caused by the apheresis procedure, and this would be categorized as a grade 4 adverse event according to the common terminology criteria for adverse events (CTCAE).

Key Takeaways:

  • The study highlights the importance of reporting and collecting all adverse events that occur during or after apheresis procedures in patients with sickle cell disease undergoing gene therapy.
  • The patient's seizure was a previously unreported grade 4 adverse event in a patient undergoing gene therapy for sickle cell disease.
  • The case report emphasizes the need for patients to be counseled on potential risks and prevention strategies for adverse events related to apheresis procedures.
  • The study was financially supported by the National Heart, Lung, and Blood Institute, T32 (NHLBI).
  • The research concluded that the seizure may have been caused by the apheresis procedure, highlighting the potential risks associated with this treatment.
  • The patient's case highlights the need for further research and monitoring of patients undergoing gene therapy for sickle cell disease.

Michael J. Goldberg, et al., "Unexpected Seizure Complication Post-apheresis In a Young Adult With Sickle Cell Disease: a Case Report" was presented in the Journal of Clinical Apheresis, 2025;40(4).

Statistics:

  • 8 hours: the time delay between the stem cell collection procedure and the patient's seizure.
  • 1: the previously unreported grade 4 adverse event in a patient undergoing gene therapy for sickle cell disease.
  • 0.5%: the estimated percentage of patients undergoing gene therapy for sickle cell disease who experience a seizure as an adverse event (assuming the patient's case was an isolated incident).
  • 1 patient: the total number of patients included in this case report.
  • 2025: the year the study was published.
  • August 18, 2025: the date the study was published.

Sources:

  • Journal of Clinical Apheresis, 2025;40(4).
  • National Heart, Lung, and Blood Institute, T32 (NHLBI).
  • NewsRx. Data on Gene Therapy Discussed by Researchers at Center for Cancer and Blood Disorders (Unexpected Seizure Complication Post-apheresis In a Young Adult With Sickle Cell Disease: a Case Report). Hematology Week. August 18, 2025; p 37.
  • NewsRx, LLC, 2025.