Process

Process 2018-04-27T20:41:49+00:00

The BioIntegrate Process

BioIntegrate only only uses human umbilical cord derived stem cellular tissues. These umbilical cord tissue donations come from consenting, disease-free, healthy donors.

BioIntegrate’s human umbilical cord tissue regenerative medicine products contain mesenchymal stem cellular tissues that are safe and provide a reliable source for physicians. This therapy is non-invasive for donors and patients, and because it is not surgery, it avoids the risks of surgery such as infection, blood clot and the recovery period.

The tissue is obtained from safe, reliable hospital sources with informed donor consent and strict ethical protocols. The tissues are taken during a non-invasive, simple procedure. Umbilical cord donation is regulated by the American Association of Tissue Banks (AATB) for quality, safety and ethics. The tissues are sourced from healthy donor volunteers who are stringently screened for pathogens in order to assure the product is safe.

Process for Cord Tissue Donation

BioIntegrate’s High Safety Standards:

All BioIntegrate’s non-embryonic tissue products are obtained from C-section deliveries from normal, full-term pregnancies and consenting donors.  All the tissues obtained are screened under AATB standards in order to assure the highest quality product.

Comprehensive medical and social histories of the donors are taken by healthcare technicians along with comprehensive blood testing.

BioIntegrate’s Stringent and Compliant Processing Standards

The tissues are procured, processed, and tested in accordance with standards established by the American Association of Tissue Banks (AATB) and FDA requirements.

Infectious disease testing is performed at a certified lab in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLA) and 42 CFT part 493 and the FDA.

BioIntegrate tests each step of the way to ensure the highest quality safety standards are maintained.

BioIntegrate’s products are compliant under 21 CFR part 1271 and section 361 of the Public Health Services Act

BioIntegrate’s Testing Policy

Each donor is tested for HBsAg (hepatitis B Surface Antigen), HBcAb (hepatitis B core Anti-body), HCV (hepatitis C Antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), CMV, and HCV NAT (HCV Nucleic Acid Test).

All BioIntegrate products are tested post-processing for endotoxins and to demonstrate the absence of bacterial, yeast and fungal pathogens. The products are quarantined until test results are received, reviewed and approved by BioIntegrate scientists. It is only then, that they are released for production. They are periodically retested.

All testing results are reviewed by BioIntegrate™ prior to release of our product. BioIntegrate™ takes considerable precaution with multiple steps to help ensure the safety of its products and meet all applicable compliance guidelines and standards established by the FDA.

BioIntegrate’s Proprietary Processing

BioIntegrate has developed a proprietary process which maintains the structural properties of Wharton’s Jelly of the human umbilical cord and creates a cryopreserved flowable sterile product without the use of enzymes or digestion. It is minimally manipulated and preserves the therapeutic elements of the mesenchymal stem cellular tissue, cytokines, growth factors, and other elements present in Wharton’s Jelly.

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