What is the return policy?

BioIntegrate, LLC accepts no returns of any BioIntegrate Injectable products. Although BioIntegrate LLC has taken great measures to ensure the safety of our allograft products, current technologies cannot preclude the transmission of certain diseases known or unknown, therefore, BioIntegrate LLC can make no claims concerning the biological properties and safety of allograft tissue. All tissues have been collected, processed, screened, tested, stored, and distributed in compliance with all current FDA regulations concerning HCT/Ps.

How is shipping handled?

Distribution of BioIntegrate injectable products are cryopreserved and shipped in shipping containers utilizing dry ice to maintain critical low temperatures. They are shipped directed to the licensed medical provider.

Are the products tracked?

All BioIntegrate injectables are tracked by lot number (allograft ID number). The FDA requires HCT/P products under section 361 to be traceable. Lot tracking is utilized as a course of action for documenting the management and storage of a specimen from donor to collector to the final transplant destination, and the review and reporting of the final results by a Healthcare Provider.

What are Donor Eligibility Requirements?

Donor eligibility requirements are set forth and regulated by the FDA to ensure the Donor of the Placental tissue for transplantation is free of specific infectious and communicable diseases. Donor recoveries meet and adhere to the regulations requisite to HCT/P recovery. Screening and testing of the tissue donor is verified through laboratory serology test panels. Once all criteria are satisfied, the donor placental tissue is deemed qualified for processing and transplantation. BioIntegrate’s regenerative medicine products are derived from non-embryo Umbilical Cord Tissue Donations.

Are Human Umbilical Cord Products sold in the U.S. approved by the FDA?

All BioIntegrate injectable products are categorized as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P’s) under Section 361. Currently, the FDA regulates all biological regenerative products under this Section. BioIntegrate products are processed from donated non-embryo human tissue from full term deliveries and regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service. They are in compliance with the FDA guidelines and are minimally manipulated, intended only for homologous use.

How are BioIntegrate products applied?

BioIntegrate Injectables are applied by a licensed physician via injection through a thin gauge needle to the affected area. This is a non-surgical minimally invasive procedure. Because it is minimally invasive, it does not carry the greater risks of surgery or the lengthy recovery that follows. And, there is no down time for the patient.

What is Wharton’s Jelly?

Wharton’s Jelly is a gel-like tissue in the umbilical cord that cushions, supports and protects the umbilical arteries and vein. Wharton’s Jelly may be preferred over amniotic membrane or amniotic fluid in many instances because it contains a higher concentration of long-chain hyaluronic acid, cytokines and growth factors; up to 50 times more. WJ tissue yields the highest concentration of allogeneic MSC’s when compared to adipose tissue.1 Picture caption: Cross-sectional diagram of human umbilical cord showing anatomical compartments, including Wharton’s jelly, as a source of stem cells. Source: Int J Mol Sci 2013 Jun; 14(6) 11692-11712.

Why are Human Cell and Tissue Products from Umbilical Cord Tissue effective?

Numerous medical studies show that umbilical cord tissue mesenchymal stem cells have a faster doubling time than adult mesenchymal stem cells (because they are younger and contain a higher concentration of growth factors). The fitness of adult mesenchymal stem cells declines with age and the number of MSC’s we have in our bodies also declines with age. Thus, cord tissue mesenchymal stem cells will have greater fitness than older adult mesenchymal stem cells (as well as a different profile of growth factors), and there will be more of them. Younger cells, like the ones found in the umbilical cord, are more energetic in the body and have a better chance of being more effective.

What is Allograft Tissue?

An allograft is tissue that is surgically transplanted or injected from one person to another.

What are Growth Factors?

Growth factors are powerful agents that are capable of stimulating cellular migration, cellular growth, cellular duplication, and cellular differentiation. They can act on target tissues and regulate a variety of cellular events. Modulation of growth factors at the injury site of a damaged tissue is one of the strategies used to stimulate tissue regeneration. Growth factors can be found in the human umbilical cord and amniotic membrane. Thousands of growth factors are contained in BioIntegrate products and they help signal local cells to help heal the damaged tissue.

What are Mesenchymal Stem Cells?

Mesenchymal Stem Cells (MSCs) are multipotent (capable of differentiating into more than one type of new tissue) adult stem cells and are partially defined by their ability to differentiate into tissues including adipose (fat), cartilage and bone cells. The International Society for Cellular Therapy states that MSCs must express certain surface markers: CD90, CD105 and CD73, and lack certain other ones CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR surface molecules. MSCs are traditionally found in bone marrow. However, they can also be isolated from other tissues including human umbilical cord tissue, cord blood, placenta, peripheral blood, and adipose tissue. The other types of stem cells are: embryonic stem cells and induced pluripotent stem cells. MSCs play a pivotal role in tissue homeostasis and renewal. As we age, there are less of these available and they live in the bone marrow and fat or adipose tissue. However, they can also be found in the umbilical cords (including the Wharton’s Jelly) and placental tissue. Given their unique regenerative abilities, stem cells offer new potentials for treating a host of diseases. They have anti-inflammatory properties as well as many other healing effects that make stem cells an exciting non-surgical alternative to treat many disorders, especially sports related injuries and arthritis.

Stem cells are a class of undifferentiated biological cells that can develop, through a process called differentiation, into many different types of specialized cell types in the body such as skin cells, brain cells, etc. They appear to be one of the body’s best tools for self-repair. Given the right stimulation, stem cells differentiate into cells that make bone, tendon, cartilage, and ligaments. They may be used to replace cells and tissues that have been damaged or lost due to disease.

What is Regenerative Medicine?

According to the National Institutes of Health, Regenerative Medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. This field holds tremendous promise for regenerating damaged tissues in the body by stimulating previously damaged tissues to repair themselves. The Mayo Clinic calls regenerative medicine a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair.

Additional – FAQ – Bio Integrate

Additional – FAQadmin2020-04-30T19:58:18+00:00

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