FREQUENTLY ASKED QUESTIONS
What are stem cells?
Stem cells are the basic building blocks of human tissue. They have the ability to repair, rebuild and rejuvenate tissues throughout the body. When disease or injury strikes, stem cells respond to specific signals and set out to facilitate the healing process by differentiating into specialized cells. These specialized cells then release healing growth factors in response to the distress cell signal in an injured or pathologic area of the body required for the body’s repair.
What type of tissue is utilized in Predictive’s products?
Our human cell and tissue products are derived from the umbilical cords of healthy, full-term deliveries. Our products do not contain any embryonic or fetal tissue
How are the tissue donors screened?
Comprehensive medical and social histories of the donors are obtained and reviewed. All tissues are procured, processed and tested in accordance with FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a registered laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.
How long does a procedure with Predictive products take?
Depending upon the area being treated, the procedure can be completed in a single office visit. Your physician will be able to provide details specific to your treatment plan.
Does my age matter when I receive treatment with Predictive products?
Your age can play a factor in the outcome of your treatment. Your physician will be able to provide you with more specific information in regard to your treatment outcomes.
Does the procedure hurt?
The use of Predictive's products does not require any invasive procedures, resulting in less pain and a shorter procedure time.
When will I begin to feel the benefits from using a Predictive product?
Depending upon the severity of the injury and your personal health, recovery time can vary. Your physician will be able to provide you with more information regarding your recovery timeline.
Are Predictive's products safe?
Our products are rigorously tested to FDA guidelines in our CLIA registered lab. Thousands of patients have used Predictive’s tissue allografts with no adverse effects.
Can I use Predictive's products if I have cancer?
Predictive's human cell and tissue products are not recommended for use in patients who are currently undergoing treatments for cancer. We recommend that patients who are specifically interested in using CoreCyte™ be cancer free for a minimum of 5 years.
Will my DNA be altered if I receive a human cell and tissue allograft?
In certain cases of bone marrow transplants, a patient’s DNA can be altered or shared with the donor. For the intent and purpose of Predictive’s products, your DNA will most likely not be altered. Most procedures utilizing human cell and tissue products in regenerative medicine will typically be removed by normal body processes within 3-14 days, and in some cases up to 120 days.
How do I get started?
You can contact Predictive Biotech by clicking the link below. A Predictive team member will reach out and provide you with a list of referrals in your local area.
Do your products utilize expanded or cultured cells?
We do not isolate, expand or culture any tissues or cells. We utilize a mechanical process to preserve the integrity of Wharton’s Jelly, which contains important growth factors, proteins, cytokines, mesenchymal stem cells and other native molecules.
How do you ship your products?
Our products are supplied and shipped frozen overnight (-80 Celsius, on dry ice). Our products are not intended to be stored in this matter, but can be kept on dry ice for up to 72 hours from time of shipment. If the allografts are not used upon arrival, they must be transferred immediately to a -196 Celsius cryofreezer and stored until the product is used or the expiration date reached.
Will you provide a cryofreezer to store the allografts?
A cryofreezer, including service and maintenance, is provided at no cost, given ordering volume requirements are met. For more information, please contact us via the link below and one of our sales executives will answer any questions you may have in regards to pricing and walk you through the steps for placing an order.
Is cryopreservation necessary?
Cryopreservation is the process of freezing biological material at extreme temperatures, most commonly in liquid nitrogen (N2) at 196°C/-321°F. At these low temperatures, all biological activity stops, including the biochemical reactions that lead to cell death and DNA degradation. This preservation method, in theory, makes it possible to store living cells and other biological material unchanged for centuries. It is this process that ensures the viability of the tissue used in our products.
What is DMSO? What is it used for?
DMSO, also known as dimethyl sulfoxide, is used as a chemical agent to protect biological tissue from the damaging effects of freezing.
Is DMSO safe?
DMSO has over 50 years of safety data and is even prescribed by physicians for pain management of wounds, burns, and other muscular and skeletal injuries. We utilize DMSO as a cryoprotectant at concentrations of less than 10% by volume.
If I have a patient who is allergic to sulfa drugs, will the DMSO cause a reaction?
DMSO does not have the same molecular structure as sulfonamides (sulfa drugs), and will not illicit the same sulfonamide allergy. However, if a patient is sensitive to DMSO then we do not recommend the use of our products.
Do I need any special equipment to thaw the products?
No special equipment or machinery is necessary to thaw the allograft products. Detailed instructions are provided with every order.
Can I refreeze the allograft after it has been thawed?
No, you cannot refreeze the allograft once it has been thawed. If a thawed product has not been used it must be discarded.
Can I divide the contents of the vial and use it on more than one area of the body on the same patient?
Yes, you may split the contents of a vial to be used at multiple points of injection on the same patient. For example, a physician may order 2cc of CoreCyte™ and divide the vial into two 1cc volumes in order to inject two separate joints in the SAME patient. Products CANNOT be shared between multiple patients.
Does amniotic fluid contain stem cells?
Amniotic fluid contains very little to no stem cells. The amount of stem cells that are present in the amniotic fluid is negligible.