Patients
Cell-free allografts
Cell-free allografts are tissue donations from which the donor's cells have been removed. Physico-chemical methods are used for this purpose. The process is also called "decellularization". What remains is the stable connective tissue. And this is what matters. The body cells make up only a very small proportion of heart valves and vessels. The heart valves and vessels act mainly mechanically as valves, or as blood conduits. These properties are provided by the connective tissue, which is completely preserved. Immediately after implantation, the cell-free allografts fulfill their purpose.
Acceptance by the body
Cell-free allografts are very rarely recognized as "foreign" by the patient's immune system. The connective tissue is immunologically silent. In contrast to the cells, whose surface markers are different in every person and are therefore recognized. Since the cells were washed out before implantation, they do not provoke the patient's immune system. The cell-free connective tissue offers the patient's body cells a natural environment for colonization. Different cell types gradually settle down and thus promote healing and regeneration. The natural shape and elasticity of the cell-free allograft facilitate the undisturbed blood flow.
Tissue Donation
Each individual cell-free allograft is derived from a tissue donation. The tissue can be removed many hours after complete cardiac arrest and therefore does not compete with organ donation. The tissue donation is carried out by independent, non-profit organizations with which corlife cooperates.
Sizes and availability
Although many people already donate tissue after they passed away, the need is greater. In addition, the geometry of the tissue donation must fit the recipient: a large person usually needs large allografts, a smaller person small. This is why there are regular waiting periods, which can last for months. The employees of corlife dedicate their full attention and care to each donation. With our Xellfree technology, we ensure the highest possible safety for patients.
The German competent authorities have approved these cell-free allografts for therapy:
Xellfree®-Technology
The process to a cell-free allograft takes about 50 days.
What happens during this time?
Discover more in this slideshow.
Tissue donation
Many people have decided to donate tissue. Relatives, friends and family can say their leave in peace, as the tissue is not removed until hours after the cardiac arrest. The maximum age for cardiovascular donation is 70 years.
Before the removal, a physician of the donation institution makes sure that the decision to donate tissue is still valid. During the conversation with close relatives, the circumstances of the deceased are also asked about in order to exclude possible risks for the transplantation. For this purpose, the medical records are checked and consultations are held with the treating physicians.
Once all consents have been obtained and risks have been excluded, the body is examined, opened and the heart and adjacent vessels are removed. A blood sample is tested for infection parameters. During the collection and examinations, signs of disease (e.g. infections) or signs of aging (e.g. arteriosclerosis) can be detected. In this case the donation will be discontinued.
A corlife employee checks and documents each tissue upon receipt.
Body cells are surrounded by a fat layer. The cells are dissolved in several washing cycles without destroying the connective tissue.
During the washing process the genetic material is released from the cells. The human genome consists of very large molecules, the DNA. The DNA is biochemically cut into many small pieces and thus completely inactivated.
In a further processing step, germs that were introduced during tissue donation are chemically deactivated.
Numerous washing steps follow to remove all remaining cell components and processing chemicals.
Finally, samples are taken from each processed allograft and examined for freedom from fungi and bacteria and freedom from cells. In addition, it is checked whether the connective tissue has a healthy structure. The examination period lasts for two weeks. If all specifications are met, we consider it a cell-free allograft.
The cell-free allograft is securely packed and labelled. Cell-free allografts are medicinal products. The "Xellfree Process" meets very high requirements, which have been approved by the German competent authorities and are continuously monitored.
Allocation
The donation institution, the clinics and corlife coordinate the distribution of the cell-free allografts. Usually the donation institution coordinates this allocation.
Testimonials
SALAMANDRA Study
SALAMANDRA is an observational study for patients with cell-free allografts. SALAMANDRA helps to increase the safety of these implants.
Both acquired and congenital heart disease may require surgical reconstruction or replacement of heart valves and/or arteries. The use of cell-free allografts can help avoid post-operative complications, especially in children and young adults. The aim of SALAMANDRA is to observe patients with cell-free allografts over a long period of time to learn more about their safety and benefits.
SALAMANDRA is an independent study coordinated at the Hannover Medical School. Corlife contributes to the costs of the study.
Please connect with sarikouch.samir@mh-hannover.de, if you want to join SALAMANDRA.