This tissue is rich with the basic components necessary for tissue regeneration including:

• Growth Factors
• Cytokines
• Collagen
• Fibrinogen
• Hyaluronic Acid
• Messenger RNA
• Mesenchymal stem cells

Amniotic tissues have proven to be multipotent and capable of differentiating into adipogenic, osteogenic, myogenic, endothelial, neurogenic, and hepatic cell lineages. This cellular component may provide an ancillary benefit.

Amniotic tissue qualifies as allograft under 21 CFR Part 1271 and section 361 of the Public Health Service Act. It is minimally manipulated (nothing added). This means that the FDA recognizes that the properties of amniotic membranes are approved for use as long as the tissues are for homologous use (which is defined as the product performing the same basic function in the donor and in the recipient.

Although the popularity in orthopedics and pain management is relatively new, amniotic derived products have a 100-year history of being used in other disciplines for its healing properties.

The amniotic membrane does not express HLA-A, -B, or -DR antigens. The chorion which has been known to cause an antigen response has been removed from the tissue at processing.

The amniotic membrane serves to protect the embryo in utero and possesses many different growth factors that serve to protect the developing fetus. These growth factors regulate a host of different physiologic functions that contribute to cell proliferation, cell migration, and cell growth. Additionally, Amniotic tissue contains collagen substrates, the full range of growth factors, amino acids, carbohydrates, cytokines, hyaluronic acid, fibroblasts, epithelial cells, extracellular matrix, micronized amniotic membrane, and mesenchymal stem cells.

Allograft tissue derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of the scheduled cesarean section. Expectant mothers submit their past medical and social history and a detailed risk assessment is performed.

Amniotic tissue has been used in wound care and is highly effective in both promoting re-epithelialization and suppressing inflammation. Amniotic tissue provides a new basement membrane that helps in the migration of epithelial cells, reinforces adhesion of basal epithelial cells, promotes epithelial differentiation, and prevents epithelial breakdown. It also down-regulates TGF-beta signaling, responsible for fibroblastic activation in wound healing. This inhibits fibroblast proliferation and prevents fibrosis.

Bone marrow-derived products come from recently deceased donors. Two big challenges in the recovery of healthy tissue are the donor age as well as the time of death to recovery. Both have negative consequences on the health of the allograft in general.

We are a nutritional regenerative soup that contains growth factors, cytokines, fibroblasts, keratinocytes, and MSC’s derived from human fetal tissue, we are a human transplant allograft. It is the power of the balanced growth factors that allow our Flow product to be so effective and safe, additionally, it is minimally manipulated so that we do not add anything that can cause a reaction as described in the attached article.

There is a huge difference in the literature between the types of cells we utilize and those that are obtained from autologous harvest and then concentrated and cultured.

Ultimately, approval of the tissue for use is made by the Medical Director following an intensive and complete medical review and pre-natal evaluation prior to delivery.

We examine:

• Tissue harvest and release criteria
• Identification of the donor
• Medical record or hospital chart
• Treating physician interview
• Family interview
• Serologic testing
• Physical assessment of the donor
• Tissue evaluation
• Donor history evaluation
• Medical director oversight

Screening Exclusions:

+ Creutzfeldt-Jakob disease (CJD)

+ Family history of blood relative with CJD

+ Recipients of human pit-hGH from 1963-1985

+ Recipients of non-synthetic dura matter grafts

+ Progressive encephalopathy

+ Encephalitis: active vim1 or of unknown origin

+ Neurologic disease of unestablished diagnosis

+ Progressive multifocal leukoencephalopathy

+ Subacute sclerosing panencephalitis

+ Reyes syndrome

+ Rabies

+ Recreational Drug use

+ Prescription medication use

+ Age below 18 and over 35 years of age

Once the placental tissue and fluid are harvested it is sent for serological testing, this same testing is repeated 2 additional times before the product can be released for implantation serological testing includes:

All tissue is held in quarantine until microbiological and blood tests are completed. These tests are required by the AATB and the U.S. Food & Drug Administration (FDA) and include analysis of infectious diseases including HIV, hepatitis B and C, and syphilis.

Processing and packaging are performed using sterile techniques in clean room conditions to maintain biological integrity. On occasion, low dose radiation is used to aid in sterilization. Final processed tissues are tested for microbiological contamination in accordance with United States Pharmacopeia (USP) guidelines to ensure compliance with regulatory requirements. Although there is some theoretical risk for disease transmission, the use of allografts that have undergone rigorous donor screening, serological testing, and formal processing has significantly reduced this risk.