Investigational FMT for Recurrent C. difficile
OpenBiome distributes investigational FMT preparations manufactured by the University of Minnesota under an Investigational New Drug (IND) application. Registered physicians may request investigational FMT preparations for the treatment of recurrent C. difficile infections not responsive to standard therapies.
How to Place An Order
To request investigational FMT treatments manufactured under an Investigational New Drug (IND) application, clinicians must register and be approved to participate in the OpenBiome Clinical Network, place an order, and review our Frequently Asked Questions.
Step 1: Join the OpenBiome Clinical Network
Before placing an order, your practice or medical facility must complete a registration form and return it to our clinical outreach team. We are required to record every shipping location, including individual facilities within the same health system. If your registration is approved, you will be added to the OpenBiome Clinical Network.
Note: University of Minnesota (UMN)-specific registration forms are required to access investigational FMT preparations manufactured by the University and distributed by OpenBiome. If you are already a registered OpenBiome clinical partner, you still need to complete the UMN-specific registration form to access investigational FMT prepared by the University.
Once your registration is complete, you will be issued a partner ID number. Not sure if your facility has registered or forgot your partner ID? Contact us at info@openbiome.org.
Detailed Registration Instructions
The registration form is a legal document that must be completed in its entirety and with no alterations to the source text. Below are guidelines for completing your Clinical Partner Registration Form:
- The clinical team may complete the information on pages 1-2.
- The terms on pages 3-5 must be reviewed by an individual authorized to purchase investigational drugs on behalf of your institution. (Clinicians are NOT generally authorized.)
- The initials on pages 3-5 must match the signature on page 6.
- When completed, return the form to us at info@openbiome.org or by fax to 617-575-2201.
- An Alternative to Registering - Contracting & Purchase Agreements: OpenBiome is happy to discuss entering into a purchasing contract with your facility or health system. For more information, please contact our Outreach Team at 617-575-2201, option 3.
Step 2: Place an Order
All OpenBiome clinical partners are eligible to place an order for an identified patient that meets the eligibility criteria for Investigational FMT under an IND and to keep a stock of investigational FMT preparations at their facility.
Submit orders by email to orders@openbiome.org or by fax to 617-575-2201. Use the OpenBiome order form or an internally generated purchase order if preferred.
Frequently Asked Questions
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