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Therapeutic plasma exchange
Therapeutic plasma exchange removes pathogenic antibodies, immune complexes, and other harmful plasma constituents by separating and replacing the patient's plasma with donor plasma or albumin solution.
Therapeutic plasma exchange removes pathogenic antibodies, immune complexes, and other harmful plasma constituents by separating and replacing the patient's plasma with donor plasma or albumin solution. Used for Autoimmune neurological disorders (e.g., Guillain-Barré syndrome, myasthenia gravis), Thrombotic thrombocytopenic purpura (TTP), Vasculitis with severe organ involvement.
At a glance
| Generic name | Therapeutic plasma exchange |
|---|---|
| Also known as | Therapeutic plasma exchanges |
| Sponsor | Centre Hospitalier St Anne |
| Drug class | Apheresis procedure / Extracorporeal therapy |
| Modality | Small molecule |
| Therapeutic area | Immunology / Neurology / Hematology |
| Phase | Phase 3 |
Mechanism of action
This procedure involves extracorporeal separation of blood into cellular and plasma components, followed by removal of the patient's plasma (which contains disease-causing factors) and replacement with fresh frozen plasma or albumin. It is used to treat autoimmune and immunological disorders where circulating pathogenic factors contribute to disease pathology, such as certain neurological conditions, vasculitis, and thrombotic microangiopathies.
Approved indications
- Autoimmune neurological disorders (e.g., Guillain-Barré syndrome, myasthenia gravis)
- Thrombotic thrombocytopenic purpura (TTP)
- Vasculitis with severe organ involvement
- Certain cases of rapidly progressive glomerulonephritis
Common side effects
- Citrate toxicity (hypocalcemia)
- Hypokalemia
- Catheter-related complications
- Allergic reactions to replacement fluid
- Coagulopathy
- Infection at vascular access site
Key clinical trials
- Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
- Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) (NA)
- Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) (PHASE3)
- A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) (PHASE2)
- A Study With Imlifidase in Anti-GBM Disease (PHASE3)
- BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR) (PHASE2)
- Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE2)
- Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Therapeutic plasma exchange CI brief — competitive landscape report
- Therapeutic plasma exchange updates RSS · CI watch RSS
- Centre Hospitalier St Anne portfolio CI