1. If upon review of your medical history you become a phage therapy candidate under IPATH, your physician will need to send your bacterial isolate to a phage laboratory where our collaborators will determine if they have bacteriophage(s) in their phage library active against the bacterium or bacteria causing your illness. Most phage labs request that the patient’s purified isolate (streaked either on a petri dish, or as agar stab) be sent at room temperature via overnight shipping. The culture should be contained in a secondary container or sample bags suitable for biohazardous materials. The labs also request that any strain identification data be included in the shipment as well. This step usually takes 1-4 weeks once the bacterial isolates have been shipped. There is a possibility that matching phages will not be identified.
2. Once active phages have been identified (if they are found), they will need to be propagated, purified, and tested for endotoxin and sterility. This step usually takes 4-12 weeks. The phage labs work very hard to make sure your physician acquires the phage(s) as soon as possible for your treatment.
3. Once the phages are ready, IPATH or your physician will submit an Emergency or Single Patient Expanded Access IND application to U.S. Food and Drug Administration (FDA). If you are not being treated at UC San Diego, your physician will need to subsequently notify a local institutional review board (usually at the hospital) about the use of phage therapy according to the procedures outlined by the FDA’s IND process. We will be able to provide your physician with advice on how this is accomplished.
4. Once the FDA approves the IND, and the local IRB has been notified, the phage lab can ship the phage(s) to the treating hospital for phage administration. The dose and duration of treatment can vary with each unique patient and should be determined by the treating physician. IPATH physicians are available for treatment-plan consultations as well.