What is Amniofit?
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.
How is the Amniofit Product sourced?
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.
What Type Of Donor Screening Or Questionnaire Does The Donor Of The Eventual Amniofit Product Execute?
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.
How Is The Amniofit Injectable Quantified And Tested For Purity?
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.
How Have Exosomes And Growth Factors Been Shown To Benefit The Recipient?
The anti-inflammatory and pro-inflammatory proteins, HA (Hyaluronic Acid), and specific growth factors are known to assists in the inflammatory cascade, and healing.
What Is The Difference Between Exosomes And Growth Factors?
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).
Why Is The Combination Of Exosomes And Growth Factors In Amniofit Significant?
As stated above, we believe the Cytokines, Chemokines (recruiting normal cells), Growth Factors, and HA (Hyaluronic Acid) are all important components for reducing inflammation.
Is The Lab That The Amniofit Product Is Produced In Fda Inspected?
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.
What Is The FDA Classification Pertaining To The Amniofit Product?
Right now, the Amniofit is classified as a HCT/P Biologic.
Is The Harvesting Process For The Eventual Amniofit Product FDA Approved?
Yes, under 21CFR 1271
Do You Need Any Special License Or Permits As A Physician To Utilize The Amniofit Product?
No, physicians can use the product under their medical license (“Practicing Medicine”).
The product has been utilized in continued research since 2013.
Have Any Patients Reported Problems With The Amniofit Therapy?
Thousands of patients have received the product with no reported adverse reactions or events.
Does Amniofit Contain Stem Cells?
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.
How Are Amniofit And PRP Similar?
Amniofit and PRP (protein rich plasma) both contain growth factors and can be used in the same way.
Who Is A Potential Candidate For Amniofit Pain Therapy Protocols?
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.
What Is Functional Medicine?
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.”
How Is Amniofit Used In Functional Medicine?
Amniofit is a staple of functional medicine and has been shown by physicians to target inflammation leading to favorable results in many conditions. Amniofit as used in Amniofit protocol is focused on whole body wellness for optimal healing, this approach is similar to that of functional medicine. Because AmnioWell contains such vastly distinguished properties it may serve as an adjunct to numerous therapies (i.e., pain, beauty, anti-aging, and wellness). This adaptability is ideal when administering treatment in the form of functional medicine.
How Long Until You Can Go Back To Daily Activities Or Working Out After Amniofit Treatment?
There is little to no down time with the Amniofit treatment. Most patients are able to go back to daily activities and working after the Amniofit treatment. However, please follow the advice of your physician.
How Long Has Amniotic Fluid Been Used Medically?
Over 100 years!
What Makes The Amniofit Product Different From Other Amniotic Products?
Amniofit is a high-level, university grade product, first single donor harvested, and then filtered in a patented process.
Do Patients See Immediate Results?
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.
How Much Of Amniofit (aF) Do I Take?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
How Often Do I Take Amniofit(AF)?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
Over How Long Of A Period Of Time Do I Take Amniofit(AF)?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
What Does It Mean That Amniofit Af Has “no Live Cells"?
Amniofit is comprised of only simple proteins.
How Is Amniofit Af Administered?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
If I Decide To Inject Amniofit AF, Where Is It Injected?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
I Don’t Like Needles. What Kind Of A Needle Is Used If I Decide To Inject?
Only your doctor can tell you if Amniofit(AF) is right for you. Please consult with your physician.
Is Amniofit(AF) A Miracle Substance?
Amniofit(AF) makes no claims at to the substance being a miracle.