• Placental tissue acts as an immune-privileged protective barrier during fetal development
• Acts as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth factors
• Proprietary process preserves the natural properties of placental umbilical cord tissue, maintaining inherent levels of key extracellular matrix molecules, including proteins, carbohydrates, growth factors and cytokines
• Contains viable endogenous cells cryopreserved in a proprietary DMSO-free cryoprotectant
Cryo-Cord™ is intended for use as a soft tissue barrier or wound covering.
Cryo-Cord™ has no known contraindications.
The donors of Cryo-Cord™ are screened and tested for relevant communicable diseases and disease agents in compliance with the FDA regulations, relating to human cells, tissues and cellular and tissue-based products (21 CFR part 1271). Cryo-Cord™ is processed using aseptic techniques and microbiologically tested. Although all efforts have been made to ensure the safety of the allograft, there is no assurance that this allograft is free from all infectious diseases or microbial contamination.
Allogeneic cells or tissues can induce an immunologic response in the recipient. The possibility that a patient may develop alloantibodies should be considered for any patient who might be a future recipient of allograft tissue or cells.
Possible adverse events may include: immunologic response, transmission of disease of unknown etiology and transmission of infectious agents including but not limited to: HIV, hepatitis, syphilis or microbial contaminants.
Cryo-Cord™ must be stored at -65˚C or colder. It is the responsibility of the tissue dispensing service, tissue distribution intermediary and/or end-user clinician to maintain the allograft in appropriate storage conditions prior to further distribution or use and to track expiration dates accordingly. Appropriate inventory control should be maintained so that the allograft with the earlier expiration date is preferentially used and expiration is avoided.
|Assigned HCPCS code|
|Shelf life greater than 2 years|
|Shelf life limited||●|
|Indicated for acute wounds||●|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns|
|Indicated for venous ulcers||●|
|Contact manufacturer for usage guidelines|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Royal Biologics manufactures minimally-invasive autologous live cellular therapy products through orthobiologic device innovations that use bioactive cells to help promote healing in a range of clinical settings.