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An Adoptive Transfer Model of Rheumatoid Arthritis in Mice
Published on: June 6, 2025
Arthritis gene therapy's first death.
Christopher H Evans1, Steven C Ghivizzani, Paul D Robbins
1Center for Molecular Orthopaedics, Harvard Medical School, 221 Longwood Avenue, BLI-152, Boston, MA 02115, USA. cevans@rics.bwh.harvard.edu
Arthritis Research & Therapy
|May 31, 2008
Summary
A patient died during an arthritis gene therapy trial in 2007, leading to a temporary halt. The trial resumed with protocol adjustments after an investigation by the Food and Drug Administration.
Area of Science:
- Rheumatology
- Gene Therapy
- Clinical Trials
Background:
- An arthritis gene therapy trial was underway in 2007.
- A critical event occurred during the trial, necessitating a pause in research.
Observation:
- A participant in the arthritis gene therapy study died in July 2007.
- The clinical trial was immediately placed on hold for a thorough investigation into the circumstances of the death.
Findings:
- The Food and Drug Administration (FDA) investigated the incident.
- Following the investigation, the FDA lifted the clinical hold in December 2007.
Implications:
- The trial was permitted to resume with minor protocol modifications.
- This event highlights the critical safety considerations in gene therapy research for arthritis.
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