Regenerative medicine has the potential to change lives, so we take processing and safety seriously. From donation to administration, Cratus is unwavering in its commitment to perfecting each and every step. All of our allograft products are prepared utilizing a proprietary mechanical process; two small samples are obtained from each lot with one sent to a third party laboratory for sterility testing and the second used for internal testing to quantify our allograft composition. After the tissue has been processed and packaged into the vials, they are then cryogenically preserved and placed into quarantine. After the sterility testing has been completed and all of the information has been reviewed and approved by our Chief Medical Officer, then–and only then–are our products ready for shipment.
By thoroughly understanding the building blocks at work within the human body, Predictive is able to pinpoint specific tissue sources we believe are best suited for regenerative medicine. Our products are intentionally derived from two tissue sources: The Wharton’s Jelly layer of the umbilical cord as well as placental tissue. These rich, potent tissue sources are uniquely able to help protect, cushion and support injured parts of the body as well as aid the optimal regenerative environment.
Our products are ethically sourced from donated birthing tissues such as umbilical cords and placentas from full-term deliveries. Comprehensive medical and social histories of the donor are obtained and tissues are procured, processed, and tested to exceed standards established by FDA.
CoreCyte™ is a minimally manipulated human tissue allograft derived from the Wharton’s Jelly of the umbilical cord. It is processed to preserve the structural integrity of Wharton’s jelly for homologous use.
Our innovative human cell and tissue products are processed in our FDA registered lab. Our minimally manipulated tissue products are prepared utilizing proprietary extraction methods that reduce the loss of important structural proteins, cytokines and growth factors.
CoreCyte™ is processed from donated human tissue from full-term deliveries. Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with standards established by FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.
FDA regulatory compliance
CoreCyte™ is regulated as a human cell and tissue product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. CoreCyte™ is intended for homologous use.
Key Characteristics CoreCyte of Structural Wharton’s Jelly
Wharton’s jelly is a gelatinous substance in the umbilical cord that provides cushioning and support
to the umbilical vein and arteries. The cushioning and protective elements from Wharton’s jelly consist of a network of structural proteins, pericytes, mesenchymal stem cells, cytokines, chemokines and
This human cell and tissue product is not recommended for people who have a known sensitivity to CoreCyte™ and is not recommended for intravenous use. CoreCyte™ should not be used in patients with a known sensitivity to Dimethylsulfoxide and is not recommended for use in patients that are currently undergoing going treatments for cancer. We recommend that patients who are interested in utilizing CoreCyte™ should be cancer free for a minimum of 5 years.
1. Open product package & remove the product tube from packaging.
2. Allow product to thaw (room temperature for 5-10 minutes or hold in hand for 2-5 minutes, until ice completely melts) and invert tube several times to mix completely. After the contents have been thawed, place the vial in an upright position and gently tap it on a hard surface to transfer all the contents of the vial to the bottom.
3. To inject allograft, remove cap by unscrewing the lid counter-clockwise. Secure a 21-23G needle to syringe. Aspirate allograft into syringe