Observational studies with orthobiologics are an exciting new area, that is revolutionizing medical treatments, in a many differnent areas, and providing hope for those who have none. Orthobiologics are therapies developed from biologic (natural) substances that can be used by orthopaedic specialists to relieve pain and aid healing.
Our founder has personally undergone this life-saving treatment for her own end-stage liver disease. We are sympathetic to the hurdles that people with these diseases must navigate. We have access to resources and networks that few others can offer.
If you are interested in a Volunteer observational study for orthobiologics click below and fill out the form as completely as possible.
Although many biologics have been found, and are used in hundreds of clinical trials, in most use cases they have not yet been approved for human use in the US, where FDA approval normally costs $1.5 million per drug. But many uses have been approved in some other countries and they are being used for a variety of diseases. Also many uses are unregulated in international waters. They can be a life changer, for some diseases, and the "Medical Tourism" industry has grown into a $100 billion industry, because some of us can not wait. If you can not wait, contact us.
We want to make something available now, to those without good choices, and leverage the money and data from these voluntary clinics to work towards making these treatments more available to more people. You can get help, while helping others.
Our upcoming event in Florida is designed to offer three orthobiologic and exosome infusions to RTT patients, many of whom have exhausted conventional medical options. XzBio’s co-founder, Robyn, is one of these patients. Diagnosed with terminal stage 4 cirrhosis, she faced roadblocks in securing a liver transplant and ultimately found another path to improve her quality of life using a proprietary treatment.
Now, we want to extend this same opportunity to others in similar situations. Also, this will allow us to collect data that may help others.
The Right to Try Act (RTT) is a way for people who have been diagnosed with life-threatening conditions, who have exhausted the normal treatments, to access investigational treatment options. The FDA has information on this on their web site fda.gov, but basically this expanded access program is a way to give hope to patients with few options in the mainstream medical world.
When people can not get the care they need in their own country, many travel to other countries, where the rules are different. Every country has it's own rules, so it can get complicated. There are even international areas, that have their own rules. This type of travel has been dubbed "Medical Tourism" and is estimated to be $100 billion today, with expectations that it will triple in the next few years. Medical tourism has become so common that the AMA and CDC have published some guidance on it on their web sites.
You may be eligible for the Right to Try (RTT) if you have a terminal disease, and have run out of options, or if you have been told that your syndrome can be terminal. If you have been turned down for a liver transplant, or can not afford one, then orthobiologics may be an option for you.
We started this company, after our founder went through various expensive treatments and testing, only to be told, that she could not receive a liver transplant, which was considered the last option. However, orthobiologics and RTT, now have her back on track with her life, either in remission or (we hesitate to say) cured.
Some people have not yet gone through all of their resources (as our founder did) getting test after test, and ineffective treatments. If you are fortunate in that way, orthobiologic treatments can be cheaper and safer than surgery. Obviously, we can not give you medical advice, unless you consult one of our doctors. Every case is different. Humans can be complicated. But Robyn often wishes that she had known about this option before blowing her life savings on ineffective treatments and false hopes.
If you do not have to Right to Try, you may speak to your MD about this. Otherwise, there are options and tools, such as Support groups, Medical Tourism, personal fundraising, that may be helpful.
You may have heard about exosomes, as being microscopic packages of RNA, proteins, and other factors. They are secreted by many human cells, and are often targeted to other tissues in the body. These packages influence the targeted cells in positive ways. Here is a popular Ted Talk that explains more about this exciting new area of regenerative medicine.
The way that biologics work varies with each product. In theory, biologics interact with your body's own cells and tissues to stimulate healing responses to a variety of conditions, including in areas that tend to heal poorly on their own.
For example, exosomes or platelet rich plasma (PRP) has been widely used for many conditions including lateral epicondylitis, or tennis elbow, delivering multiple healing factors (contained in the platelets) to the irritated tendons in the elbow to promote healing and decrease pain.
Turned down for a liver transplant? Bleeding money for test after test, with no useful result? There is hope. Our founder had the same experience, and paid for test after test, and turned down over and over for liver transplant. Then she found orthobiologics, for her own end-stage liver disease.
We want to help you find the latest information and what your options are.
If you are considering an out-of-country option, medical tourism, you may want to read this:
https://wwwnc.cdc.gov/travel/yellowbook/2024/health-care-abroad/medical-tourism
If you want to read about the FDA and Right To Try, please read this:
Read more on Right To Try:
General info: https://en.wikipedia.org/wiki/Right-to-try_law
FDA document: https://www.fda.gov/media/133864/download