Cellbiotix FAQ
TOPICS COVERED IN THIS FAQ:
• The Cellbiotix Process & Blood Draw
• Why Now?
• Cell Storage
• Your Biobank
• Privacy & Security
• Biology 101
THE CELLBIOTIX PROCESS & BLOOD DRAW:
How do I get my blood drawn?
Your Health Care Provider will collect your blood sample, package the kit for delivery to our lab for processing. In about two weeks the results of your stored materials will be sent to your health care provider.
How do I prepare for my blood draw?
Try to get a good night’s sleep before your test. The amount of blood drawn is minimal, so fainting, lightheadedness and nausea are unlikely. Tell your blood draw technician if you have had issues with blood draws in the past.
Are there risks associated with a blood draw?
The risks associated with blood draws are extremely minor. You may experience slight bruising, discomfort or inflammation after the draw.
What if I cannot produce 40 mLs of blood during my appointment?
No need to worry! Even in the highly unlikely event that we are unable to collect enough blood to fill the vials, we will still process and store your sample. Then, if needed, we will get in touch with you to schedule an additional blood draw, so you can take full advantage of everything Cellbiotix has to offer.
WHY NOW?
Why is it important to store my cells now?
As we age, so do our cells. Cells can make mistakes when they copy DNA, and not all mistakes get fixed. Outside forces, like UV radiation, can also damage our cells over time. When this happens, our bodies continue to reproduce weakened cells with mistakes embedded in their genetic codes. That is why older cells are not always as equipped to correct DNA damage, generate new cells, produce energy, and fight disease. These genetic mistakes (or mutations) accumulate more rapidly as our cells age. Aging is a critical issue for stem cells, which are tasked with repairing damage throughout the body.
The best cells you will ever have are the ones you have right now. Storing them means you can use your younger, healthier cells instead of your older, weaker ones when it comes time to fight off future diseases. Biobanking with Cellbiotix might give you an upper hand against cancer, Parkinson’s disease, macular degeneration, heart disease, and a host of other medical conditions.
Read more about the effects of damage on stem cells, , and how damage to cells affects aging to help you make an educated decision to protect your health.
CELL STORAGE:
How do I know that my sample is stored safely?
Our bioprocessing laboratory and storage facility is Clinical Laboratory Improvement Amendments (CLIA) certified, ensuring proper handling and secure storage of your biological samples for years to come. Temperature-regulated storage devices (including freezers and liquid nitrogen dewars) are individually alarmed, monitored around the clock, and backed up by onsite electrical generators. Our facility houses millions of samples and is trusted by the National Institutes of Health, as well as the largest pharmaceutical companies in the United States.
How can I access my sample when I need it?
If you ever need to use your sample, we will ask for a written medical letter from a doctor as proof of necessity. We will work directly with your healthcare provider to make sure they can access the cells as needed.
​
Upon your request and consent and working with your physician or a clinical researcher, we will transfer your cells to the identified facility, or an FDA-approved storage facility.
How many times can I use my sample?
The number of viable stem cells in your sample is limited, so you cannot use them indefinitely. The number of times you can use your stored stem cells depends upon both which and how many stem cells you need for a specific use. With that said, you can use your DNA and blood plasma multiple times, if needed.
Is there an additional cost for retrieving my sample?
Yes, should you wish to retrieve your sample and have it delivered to another location, there are additional costs for shipping and handling to ensure your cells get to their destination in good condition.
Is there a storage fee?
Your storage fee is covered by your lifetime membership.
What happens if I miss a payment?
Nothing will happen to your sample if you miss a payment. We will continue to contact you for payment for 60 days. If you have not paid for more than 60 days, Cellbiotix reserves the right to gain ownership of your sample for research purposes.
How long will my stored cells last?
Once your cells are cryopreserved, we keep them at a tightly regulated temperature for indefinite storage, until you need them. There are no studies (yet) on how these particular cells hold up over time in cryostorage. However, studies have shown that cord blood cells preserved in the same way were viable and functional for transplant after more than 25 years in storage.
Read more about: longevity of cryogenically preserved biological samples.
What kind of stem cells does Cellbiotix store?
We currently store tissue-specific blood stem cells, which are used today to treat many forms of cancer, as well as some immune diseases. We do not store induced pluripotent stem cells (iPS cells). Instead, we store specific types of white blood cells (also known as leukocytes or peripheral blood mononuclear cells - PBMCs).
Scientists have developed methods to easily and efficiently turn white blood cells into induced pluripotent stem cells (iPS cells), which may be very effective in treating certain diseases.
Does Cellbiotix collect and store mesenchymal stem cells?
Cellbiotix can isolate and store these kinds of cells under other membership plans, though these stem cells could be derived from induced pluripotent stem (iPS) cells, which we can easily generate from the white blood cells that we store in our Base Membership.
How long have stem cells been used in treatment and therapy? Are stem cells safe?
Stem cells have successfully helped treat a wide range of medical conditions for over 50 years. Specifically, hematopoietic progenitor cells (HPCs), also known as blood stem cells, are a powerful tool for replenishing diseased blood systems and even curing blood diseases. HPC transplants are a common and effective treatment for certain cancers, metabolic disorders, and recently, autoimmune diseases.
Stem cells are also the basis for skin grafts used to treat burn patients and bone grafts for orthopedic injuries. An abundance of active international research aims to develop stem cell therapies to treat cancers, neurodegenerative diseases, diabetes, heart disease, and many other conditions.
When used in research-backed, FDA-approved ways, stem cell therapies are both safe and effective. Currently, there is a relatively small number of such therapies, but research is growing steadily. More than 100 trials are underway around the world right now.
Some companies and organizations tout stem cells as cure-alls or miracle treatments that can fix any medical concern. However, that is not the case - at least not yet. Cellbiotix never condones, promotes or engages in stem cell therapies until they have undergone several years of clinical investigation.
We believe that in the future, maybe even the near future, stem cells will offer superior treatment for various diseases and conditions. Since medical research is ongoing, it is imperative that anybody considering a stem cell treatment understands exactly what they are getting.
Who is handling the blood?
All our partners who handle your blood are CLIA/CAP certified medical clinical laboratories that comply with HIPAA. For more information on HIPAA compliance: https://www.hhs.gov/hipaa/index.html
​
Our laboratory testing and material storage is for medical purposes and is not used for research unless you specifically consent to be involved in research.
Is the blood sample stored in a CLIA certified laboratory?
Our bioprocessing laboratory and storage facility is Clinical Laboratory Improvement Amendments (CLIA) certified, ensuring proper handling and secure storage of your biological samples for years to come. Temperature regulated storage devices are individually alarmed, monitored around the clock, and backed up by onsite electrical generators. The facility we use houses millions of samples and is trusted by the National Institutes of Health, as well as the largest pharmaceutical companies in the United States.
Are there any options to have my DNA sample destroyed?
You will always have the option to have your materials destroyed (cells, DNA and plasma) destroyed at any time. The benefits of storing your DNA, plasma and cells are detailed at length on our website.
What age is too old to participate?
There is no exact cutoff age for which personal biobanking is no longer advised. While cellular health generally declines with time, cellular health and potential therapeutic needs are unique to the individual.
For those thinking about participating in personal biobanking and wondering about age requirements, Cellbiotix recommends an individualized approach – take note of the disease(s) that may impact you, know the disease’s average onset and assess how close in age you are, and determine if there are any clinical trials in progress for those disease(s).
Is there any value in storing your cells if you’re too old to benefit personally?
Yes, there are valuable reasons to store your cells, even if you do not believe you would personally benefit from future cellular therapies.
Tests are being developed that can utilize an individual’s own cells to screen for which drug may be best to treat disease or have the least side effects in doing so.
​
Additionally, stored cells can be used for biological relatives. Biological relatives are more likely to be a match for cell therapies than unrelated donors making the storage of your cells now significantly beneficial for your biological family members in the future.
If I’ve had cancer (or other diseases), can I still participate?
Yes. The cells, despite disease, may still be utilized and there are other advantages to biobanking such as evaluating genetic risk of diseases and processing the plasma in your blood to track the various biomarkers circulating in your body which may indicate your state of health.
Are there any treatments available now using iPSCs?
Currently there are a handful of FDA-approved stem cell therapies, mostly in the areas of bloodborne cancer. There are 25 clinical trials underway using iPSCs with 20+ in pre-clinical trials.
​
* FDA, 2019
What happens if I am no longer able to make use of my stored cells?
Should you no longer need to store your cells, such as in the event of a death, your biomaterials will be fully anonymized and stored for potential research. They will not be identifiable or connected to you in any way.
YOUR BIOBANK
How does Cellbiotix secure my stored cells?
We process and store your sample in our state of the art, CLIA/CAP certified lab and biorepository. This biorepository houses millions of samples and is trusted by large pharmaceutical companies, as well as the National Institutes of Health.
​
The site is secured and monitored around the clock, with all temperature regulated storage equipment on alarm notification and generator backup to ensure safe, controlled long term storage.
PRIVACY & SECURITY
What data does Cellbiotix collect?
We collect the information we need to provide a high-quality customer experience, including the information below. 
Personal information, such as: 
• Name 
• Sex (Assigned at Birth)
• Date of birth 
• Billing & shipping addresses 
• Payment information  
• Contact information (such as email address or phone number) 
• Protected health information 
Protected health information, such as: 
• Personal information (mentioned above) 
• Medical history (when provided) 
• Other health information provided by you 
Web behavior data, such as: 
• Browser data 
• Device information 
• IP address
How does Cellbiotix protect my information?
We take great care to use technical, administrative and physical safeguards to secure your personal information and protect it against misuse, loss or alteration. Your information is processed and stored with restricted access. 
What is identifiable data?
Identifiable data includes protected health information, such as information about your health status, any healthcare you have received, or payments for healthcare that can be linked back to you as an individual. This includes your medical records and payment history.
How does Cellbiotix use identifiable data?
We use your identifiable data to provide our services to you. Please see the “How does Cellbiotix protect your information” section above for details on how we keep your identifiable data secure.
Does Cellbiotix share identifiable data outside of the company?
Cellbiotix  will never sell or lease/rent your identifiable data to any third party (including academic researchers) without your explicit consent. 
​
That said, there are a few specific instances in which we do we share information with others to provide you with our services, including: 
• Our laboratory partners.
• A company that processes payments (and is contractually obligated to protect your privacy and security).
• Legal guardians or personal representatives (if applicable).
• Healthcare Providers you authorized.
In addition, there may be special circumstances in which we need to disclose identifiable data as permitted under the US Health Insurance Portability and Accountability Act (HIPAA), including: 
• In response to a court order, subpoena or other lawful process. 
• As otherwise required by applicable law.
What is de-identified data?
De-identified data is information that cannot be reasonably linked to a specific individual. HIPAA provides a safe harbor method for the de-identification of protected health information, which includes the removal of the following 18 identifiers: 
• Name 
• Specific geographical identifiers 
• Dates (other than year) directly related to an individual 
• Phone number 
• Fax number 
• Email address 
• Social Security number 
• Medical record number 
• Health insurance numbers 
• Account number 
• Certificate/license number 
• Vehicle identifiers and serial numbers (e.g., license plate numbers) 
• Device identifiers and serial numbers 
• URLs 
• IP address 
• Biometric identifiers, including finger, retinal and voice prints 
• Full face photographic images and any comparable images 
Any other unique identifying number, characteristic or code Cellbiotix removes all the identifiers listed above. 
​
Once all these identifiers are removed and precautions are taken, we believe that the de-identified data cannot reasonably be traced to you or used to identify you or your medical information as an individual. 
When does Cellbiotix share de-identified data?
We share de-identified data in specific ways that help advance medical care and the clinical practice.
What are the benefits of sharing de-identified data?
Sharing de-identified data helps to accelerate medical research and is an essential component of improving identification, treatments, medications and therapies.
In addition to customers owning and controlling their genetic data, Cellbiotix also believes that your de-identified information is more valuable when shared. We encourage customers to choose to share their de-identified information with the medical and scientific community to help accelerate our understanding of medical conditions, improve testing and find new therapies.
How can I let Cellbiotix know of my data-sharing preferences?
You can contact our Cellbiotix Support Team and inform them of your data-sharing preferences. You can contact Cellbiotix Support at (786) 207-9502 or by emailing support@cellbiotix.com.
BIOLOGY 101
What is DNA?
Deoxyribonucleic Acid, more commonly known as DNA, is the material that carries instructions, in the form of genes, for growth, development, functioning and reproduction in nearly all living organisms. DNA is a long double-stranded molecule, shaped like a twisted ladder, or double helix. DNA is made up of a sequence of four nucleotides (also called bases): adenine (A), thymine (T), cytosine (C), and guanine (G) that pair with each other in a specific way. The human genome consists of 3 billion base pairs of DNA.
What is blood plasma?
Blood plasma is a fluid that makes up a little more than half of our blood’s total volume. Plasma is the reason our blood is a liquid. Plasma is not a type of blood cell, nor does it contain any cells. Rather, it is composed of about 92% water, as well as certain proteins, nucleic acids, salts, cellular waste, nutrients and gases, some of which are important biomarkers that can indicate health status and disease.
What are stem cells?
Stem cells can develop into different types of specialized cells meant to carry out unique functions. They are found throughout the body, in a wide range of organs and tissues. Your body uses stem cells to fight infections, repair damage and even rebuild broken-down tissue. There are four general types of stem cells: embryonic, tissue-specific, mesenchymal and induced pluripotent.
Here at Cellbiotix, we are most interested in tissue-specific stem cells (especially those found in blood) and induced pluripotent stem cells, or IPS cells. IPS cells can be programmed to produce virtually any cell type in the human body - blood cells, brain cells, pancreas cells, heart cells, and more. This gives them amazing potential to help treat many diseases, including certain forms of age-related blindness, Parkinson’s disease and heart disease.
Read more about: quality of iPS cells based on age, how iPS cells are derived, quality of iPS cells derived from skin vs. other sources.
What are induced pluripotent (iPS) cells?
The peripheral blood mononuclear cells (PBMCs) that Cellbiotix stores in your personal biobank have been used to generate a type of stem cell known as an induced pluripotent stem (iPS) cell. These cells are unique and specific to you and carry the unique ability to make any cell type in the human body. As such, researchers around the globe are very excited about the potential of iPS cells to treat a wide variety of human diseases. Some clinical trials involving iPS cells have already started showing positive results.
What are hematopoietic progenitor cells (HPCs)? How are they useful?
HPCs, also known simply as blood stem cells, can transform into any of the three main types of blood cells: red blood cells, white blood cells and platelets. They are found in bone marrow, cord blood and peripheral blood.
​
For decades, doctors and researchers have known that blood stem cell transplants are effective in treating dozens of diseases, such as:
• Bloodborne cancers (e.g., leukemia, lymphoma)
• Autoimmune disorders (e.g., SCID, adenosine deaminase deficiency)
• Metabolic disorders (e.g., Gaucher disease, Niemann-Pick disease)
• Non-malignant blood disorders (e.g., polycythemia vera, sickle cell anemia)
Please note that the HPCs contained within Cellbiotix samples are currently of insufficient quantity for blood stem cell transplants. However, our capacity to expand the number of cells in the laboratory increases every year. At least two companies have already developed methods that could make the current number of stored cells sufficient, but more testing is needed. It is likely in the near future that we will be able to use the amount of blood stem cells in your sample to create enough cells for a transplant.
​
Read more about: research on using smaller numbers of stem cells for therapies.
What could I learn from analyzing my stem cells?
Stem cells are our body’s first resource for repairing damaged tissue. There is a lot we can learn from our stem cells, including how much damage they have sustained.
​
Damage to stem cells - or any cells - typically comes from one of two places: External sources, such as ultraviolet radiation (a leading cause of melanoma), or minor mistakes in DNA sequencing during cell division. When a cell divides, it must copy its DNA, so the new cell functions properly. This process happens millions of times every day, and occasionally, mistakes occur. Normally, our cells catch mistakes and destroy the damaged cell. But sometimes, mistakes go unnoticed and are copied to future cells.
​
The more accumulated damage that cells have, the less capable they may be at fighting disease.
​
Read more about: effects of damage on stem cells, changes in stem cell function based on age, how damage to cells affects aging.
Ready to get started?
Your investment today could be your body’s most potent medicine tomorrow.