FAQ

Amniofit is a unique product which plays an emerging role in Regenerative Medicine. Amniofit is a natural, sterile, protein rich, amniotic derived liquid. Amniofit fluid is harvested under FDA guidelines, then tested and quantified to consist of 900+ proteins including growth factors and exosomes per mL. The structural tissues in each unit may be used by physicians to protect and cushion, provide lubrication, and modulate inflammation. Because Amniofit contains such vastly distinguished properties it may serve as an adjunct to numerous therapies (i.e., pain, beauty, anti-aging, and wellness). There are no live tissues or cells in Amniofit, just proteins. With Amniofit, what creates life may be used to repair life.

Amniofit (Amniotic Fluid) is recovered from consented pregnant women who are scheduled to have a C-section. The women complete an Informed Consent and a Maternal Health History Questionnaire (similar to those completed for blood donation). A complete review of the donor mother’s medical record is also obtained. Just prior to the recovery, blood samples are drawn from the mother donor and sent for all required infectious diseases.

Amniofit (Amniotic Fluid) is recovered from consented pregnant women who are scheduled to have a C-section. The women complete an Informed Consent and a Maternal Health History Questionnaire (similar to those completed for blood donation). A complete review of the donor mother’s medical record is also obtained. Just prior to the recovery, blood samples are drawn from the mother donor and sent for all required infectious diseases.

Amniofit is acellular. All the dead epithelial cells and insolubles are filtered out of the product. All the soluables (i.e., proteins –growth factors, cytokines, chemokines and Hyaluronic Acid (HA) are retained. Amniowell product is sterile filtered, and tested for proteins, HA, which meet a minimum standard. The product is labeled sterile and meets USP <71) standards. How do dead cells carry exosomes and growth factors? Proteins, growth factors, exosomes, and HA (Hyaluronic Acid) are not found specifically in the cells, but are found in the supernatant fluid. We verified this through our validation process. Please contact us for our publication identifying proteins through a micro-array analysis.

The anti-inflammatory and pro-inflammatory proteins, HA (Hyaluronic Acid), and specific growth factors are known to assists in the inflammatory cascade, and healing.

Exosomes are extracellular vesicles that are released from cells, and are responsible for intercellular signaling. This is important in utero between the baby and mother. Growth factors are a naturally occurring substance capable of stimulating cellular growth, proliferation, healing, and cellular differentiation.

A growth factor is a protein or a steroid hormone. Growth factors are important for regulating a variety of cellular processes. Growth factors typically act as signaling molecules between cells. Examples are cytokines and hormones that bind to specific FAQ receptors on the surface of their target cells. They often promote cell differentiation and maturation, which varies between growth factors. For example, epidermal growth factor (EGF) enhances osteogenic differentiation, while fibroblast growth factors and vascular endothelial growth factors stimulate blood vessel differentiation (angiogenesis).

As stated above, we believe the Cytokines, Chemokines (recruiting normal cells), Growth Factors, and HA (Hyaluronic Acid) are all important components for reducing inflammation.

Yes, the lab is registered, inspected by FDA as a cGMP, and Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) regulated under 21 CFR 1271.

Right now, the Amniofit is classified as a HCT/P Biologic.

Yes, under 21CFR 1271

No, physicians can use the product under their medical license (“Practicing Medicine”).
The product has been utilized in continued research since 2013.

No.

We evaluated birth tissues for human mesenchymal stem cells (hMSCs). There are very few hMSCs in birth tissues. Our research has shown that the active or functional component in amniotic fluid are the proteins, growth factors, HA, and exosomes. We filter all cells out and therefore our product is acellular.

Amniofit and PRP (protein rich plasma) both contain growth factors and can be used in the same way.

Anyone in pain, especially inflammation related pain, may benefit from Amniofit Pain therapies. Some common conditions treated by physicians include: osteoarthritis, knee pain, shoulder pain, nerve pain, back pain, hip pain, elbow pain, ligament injury, tendonitis/osteopathies, plantar fasciitis, slow & non-healing wounds/burns, slow healing fractures.

Functional medicine is a form of medicine that focuses on the “root causes” of diseases based on interactions between the environment and the gastrointestinal, endocrine, and immune systems to develop “individualized treatment plans.”

Over 100 years!

Amniofit is a high-level, university grade product, first single donor harvested, and then filtered in a patented process.

Doctors have noted and our videos show that some patients see immediate pain relief. Often, the pain relief is long term. Other times, pain relief is short lived followed by a healing period which eventually leads to long term pain relief. Patients should not expect any noticeable difference in any treatment prior to 90 days of Amniofit protocols.

Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.

Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.

Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.

Amniofit is comprised of only simple proteins.

Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.

Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.

Amniofit(AF) makes no claims at to the substance being a miracle.