What is Wharton's Jelly?
Wharton’s jelly is a gelatinous substance in the umbilical cord that provides cushioning and support to the umbilical vein and arteries. The cushioning and protective elements from Wharton’s jelly consists of a network of structural biomolecules, pericytes, mesenchymal stem cells, cytokines, chemokines and growth factors.
What is amniotic fluid?
Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. The fluid contains hyaluronic acid, lubrican, cytokines, carbohydrates, proteins and peptides, fats, amino acids, enzymes and hormones. Use of human and bovine amniotic fluid for orthopedic conditions was first reported in 1927.
What is the amniotic membrane?
The Amniotic Membrane (AM) is the inner layer of the placenta that surrounds the baby during pregnancy. The Amniotic Membrane is the only tissue designed by nature specifically as a universal transplant, protecting the baby and ensuring acceptance by the mother’s immune system. Its natural biologic role provides the tissue with unique structural and compositional properties that facilitate and maximize the natural wound healing capacity of the host tissue.
Does amniotic fluid contain stem cells?
Amniotic fluid contains very little to no stem cells. The amount that is present in the amniotic fluid is negligible.
What is cryopreservation?
Cryopreservation is the process of freezing biological material at extreme temperatures; most common -196 °C/-321 °F in liquid nitrogen (N2). 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 as well as other biological material unchanged for centuries.
What is DMSO? and what is 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 physicans for pain management of wounds, burns and other muscle and skeltal injuries. We utilize DMSO as a cryoprotectant at concentrations of less then 10% by volume.
If you are allergic to Sulfa medications, will you have a reaction to DMSO?
A person who has an allergic reaction to sulfa will not have an allergic reaction to a sulfur compound found in DMSO.
Sulfur is essential to life and is the eighth most prevalent element in the human body. The structure of unmetabolized sulfa drugs almost never cause a hypersensitivity reaction by themselves (the unmetabolized sulfa drug), but when a sulfonamide molecule is metabolized in the body, it is capable of attaching to proteins, thus forming a larger molecule that could serve as an allergen. Thus, the allergy is not to the original drug (the unmetabolized sulfa drug structure), but to a metabolized sulfa drug-protein complex. It is estimated that a skin rash occurs in about 3.5% of hospitalized patients receiving sulfonamides. A sulfanomide (see sample structure, below) does contain sulfur, but the sulfur atoms are imbedded in a complex molecule. The sulfur atom is not the allergenic agent and being allergic to sulfa drugs does not imply having a propensity to allergy to other sulfur compounds. Rather, it is a unique property of this kind of compound (sulfanomides), namely that it can cause the formation of protein complexs that cause allergenic reactions in some individuals. DMSO does not contain a sulfonamide group.
Do your products utilize expanded or cultured cells?
We do not isolate, expand or culture any tissues and 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.
Where do Predictive’s products come from?
Our human cell and tissue materials come from the umbilical cords of healthy, full-term deliveries. Our products do not contain any fetal or embryonic tissue.
Are Predictive's products safe?
Our products are rigorously tested to FDA guidelines in our CLIA certified lab. Thousands of patients have used Predictive’s tissue allografts with no adverse effects.
How long does a procedure with Predictive products take?
Depending upon the area being treated, the procedure can be completed in an single office visit. Your doctor will be able to provide details specific to your treatment plan.
Does the procedure hurt?
The use of our products do not require any invasive procedures, resulting in less pain and a shorter procedure time.
When will I feel the benefits?
Depending upon the severity of the injury and your personal health, recovery time can vary. Your physician can provide more information.
Does your Wharton's Jelly allograft contain any red blood cells?
Our Wharton's jelly allograft may contain trace remnants of red blood cells from the donor (less then 1% by volume). Currently, there are many studies that are being done on mismatched hematopoietic cord blood stem cell units. They attest to the fact that hetastarch and/or ficoll processing of cord blood units results in 10% red blood cell content in the stored hematopoietic product. Although a high incidence of hemolytic activity is present, research is showing no influence of ABO-mismatch on the incidence of clinically significant acute or chronic GvHD (Worel, et al., 2008; Mielcarek, et al., 2000; Canals, et al., 2004).
These studies are conducted in short timeframes, less than one year, but demonstrate that mismatches in blood type are not producing a significant immune response against the transplant material. Although the literature suggests no clinically significant impact for concentrations less than 10%, we still have concerns about the use of Umbilical Cord products that have white blood cells and hematopoietic stem cells. It is important that if any patient has an adverse effect with the use of any allograft products, that the manufacturer is notified immediately.
Can I use Predictive's products if i have cancer?
Predictive's human cell and tissue products are not recommended for use in patients that are currently undergoing going treatments for cancer. We recommend that patients who are specifically interested in utilizing CoreCyte™ should be cancer free for a minimum of 5 years.