Professional Information on Kryobiom®
Kryobiom® is a procedure for the preventive preservation of an individual’s gut microbiota. It is based on the principle of autologous fecal microbiota transfer (aFMT). It combines current microbiome research with standardized production and storage procedures.
This page is intended for medical professionals and provides an overview of:
- Methodology (collection, processing, storage)
- Regulatory framework
- Relevant scientific studies
Collection and Processing
The stool material is collected by the patient at home and then delivered to the practice.
In the practice, the following steps are performed:
- Blood testing (complete blood count, inflammatory markers, exclusion of relevant infectious diseases)
- PCR testing of the stool material for 22 pathogenic organisms
- Clearance for production only if all results are unremarkable
Further processing steps:
- Isolation of the microorganisms
- Freeze-drying
- Filling into special capsules that ensure release only in the intestine
Storage and re-administration:
- Current: Storage for up to 9 months at –80 °C (legally approved for re-administration)
- Extended: Storage for up to 30 years at –130 °C in the vapor phase of liquid nitrogen (“Microbiome Ark”, Harvard Medical School 2022)
⚠️ Note: Under current German regulations, re-administration is permitted only within 9 months. Long-term preservation currently serves preventive purposes. Stability studies are ongoing; users will be informed as soon as authorities allow longer re-administration periods.
Scientific Studies
Design and manufacture of a lyophilised faecal microbiota capsule formulation to GMP standards
Nur Masirah M. Zain et al., Journal of Controlled Release 350 (2022) 324–331
Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT
Suez et al., 2018, Cell 174, 1406–1423
Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients
Florent Malard et al., Nature Communications volume 12, Article number: 3084 (2021)
Freeze-dried fecal samples are biologically active after long-lasting storage and suited to fecal microbiota transplantation in a preclinical murine model of Clostridioides difficile infection
Julie Reygner et al., Gut Microbes (2020), Vol. 11, No. 5, 1405–1422
A Guide for Ex Vivo Handling and storage of stool samples Intended for Fecal Microbiota transplantation
Sebastian D. Burz et al., Nature, Scientific Reports volume 9, Article number: 8897 (2019)
The Odyssee Study: Prevention of Dysbiosis Complications with Autologous Fecal Microbiota Transfer (FMT) in Acute Myeloid Leukemia (AML) Patients Undergoing Intensive Treatment: Results of a Prospective Multicenter Trial
Mohty et al, Blood (2018) 132 (Supplement 1): 1444
Autologous fecal microbiota transplantation can retain the metabolic achievements of dietary interventions
Ehud Riot et al., European Journal of Internal Medicine
Volume 92, October 2021
Autologous fecal microbiota transplantation for the treatment of inflammatory bowel disease
Abigail R Basson et al., Transl Res. 2020 Dec.
Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients
Florent Malard et al., Nature Communications volume 12, Article number: 3084 (2021)
Effects of Diet-Modulated Autologous Fecal Microbiota Transplantation on Weight Regain
Ehud Rinott et al., Gastroenterology 2021;160:158–173
Regulatory Framework
- Production and application as an individual medicinal product according to §21 Abs. 2 Nr. 1 AMG
- Production takes place in a medical practice; no industrial manufacturing
- Re-administration currently permitted only within 9 months – long-term storage (–130 °C) is possible as a preventive measure