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CoreCyteTM is a minimally manipulated human tissue allograft derived from the Wharton’s Jelly of the umbilical cord. CoreCyteTM is processed to preserve the structural integrity of Wharton’s jelly for homologous use and cryogenically preserved.
A) Innovative Development
Predictive Biotech’s innovative human cell and tissue products are processed in our FDA registered lab. Our minimally manipulated tissue products are prepared utilizing proprietary extraction methods that reduce the loss of important structural proteins, cytokines and growth factors.
B) Quality Assurance
CoreCyte™ is processed from donated human tissue from full-term deliveries. Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with standards established by FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.
C) FDA regulatory compliance
CoreCyte™ is regulated as a human cell and tissue product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. CoreCyte™ is intended for homologous use.
440+ Cytokines Interleukins Growth Factors Chemokines
Cells per cm of Umbilical Cord: MSC1: 240,000
Extracellular Matrix Composition: Collagen 3.6% Glycoprotein 0.3% Hylauronin 0.31%
AmnioCyteTM is processed to preserve the cytokines, growth factors and proteins in amniotic fluid for homologous use.
AmnioCyte PlusTM is processed to preserve
cytokines, growth factors and scaffolding proteins
in amniotic membrane for
PolyCyteTM is processed to preserve cytokines, growth factors, proteins, mesenchymal stem cells and structural integrity of Wharton’s Jelly for homologous use.
CoreCyteTM is processed to preserve cytokines, growth factors, proteins, mesenchymal stem cells and structural integrity of Wharton’s Jelly for homologous use and is cryogenically frozen.
One of the most difficult aspects of regenerative medicine is navigating the landscape of tissue sources for treatment. What products are derived from those tissues? What do those products contain? What don’t those products contain?
Regenerative medicine is an area of healthcare that has the potential to have a disruptive affect on the way certain human ailments are managed. Allogeneic human cell and tissue products are able to supplement the body’s natural healing process.
Over time, healthy tissue can become dysfunctional due to age and injury. A human cell and tissue product (HCT/P) is administered to a recipient to repair, reconstruct, replace, or supplement the same basic functions of the recipient’s cells or tissues.
The human body utilizes a variety of tissue and cell interactions to support the healing process. Predictive’s human cell and tissue allografts supplement similar tissue in your body via scaffolding, growth factor, homeostatic and general cytokines.