Use of scCO2 for processing Allografts & Xenografts
Limited & timely availability of donor-derived tissues & allograft material for clinical application has led to the use of xenograft-derived tissues to meet clinical need. However, to meet current regulatory requirements of complete decellularization of xenografts using various agents, such as
acids & bases, hypotonic & hypertonic solutions, detergents, alcohol & other solvents, lead to denaturation of native ECM composition & activate host immune response, resulting in tissue rejection.
Carbon Dioxide (CO2) at given temperature & pressure reaches a supercritical phase with penetrative properties of a gas & washing properties of a liquid. This enables deep tissue penetration & decellularization of tissue material without damaging Extra Cellular Matrix (ECM) components & heat-sensitive native growth factors. HCM-Medical is currently manufacturing CE-approved porcine/bovine–derived pericardium membranes for dental & orthopedic applications & bone fillers derived from bovine & equine sources.
Processing of Allografts & Xenografts using scCO2
Donor/Xenograft material Processing
The donor material/xenograft tissues are meticulously selected according to EU regulations for various transmissible diseases and sourced to meet regulatory and ethical standards. The received tissues are stored, processed, and packaged under classified GMP ISO 13485 regulations separately for each species.
scCO2 Processed products
Examples of scCO2-processed allograft tissues:
The tissues are cleaned, milled to the required size, and scCO2 processed to remove cellular, DNA , and other immunogenic material without compromising the ECM structure of the native tissues.
Any Soft/Hard Tissues can be decellularized using scCO2 Technology:
We have validated processing protocols under a GMP ISO 13485 facility for various xenograft and allograft soft and hard tissues. By varying the pressure, temperature, and duration of the process, we clearly demonstrate that the tissues can be decellularized, as shown by HE staining and total DNA content analysis.
We have adapted the technology for processing various allografts and xenograft tissues, and many of our products have been in the clinic for over a decade. We are currently CMO for various global clients,
We have adapted the technology for processing various allografts and xenograft tissues, and many of our products have been in the clinic for over a decade. We are currently the CMO for various global clients
1. Porcine Pericardium Membrane for guided dental reconstruction surgeries.
2. Various Bone Allografts such as DBM, cortical, and Cancellous chips for orthopedic and dental reconstruction surgeries.
Clinical Outperformance of scCO2 Processed Allografts and Xenograft Tissues
scCO2 Processed Allografts & Xenograft Tissues
VitalTissues offers a range of Allografts and Xenograft Bone Graft Substitutes (BGS) for Orthopedic, Dental, Spinal, and Wound care applications. The donor tissues are processed using a novel trademarked supercritical CO2 technology. Vital Tissues is expanding its business globally to provide the world with its novel allograft and xenograft tissues at a low cost and superior products for orthopedic, dental, spinal, and wound care applications.
Find a complete scCO2 human bone allografts product list below