Amniotic and Umbilical Allografts

CytoVive™ is proud to offer Predictive Biotech's industry leading allogeneic treatment options. Predictive's vision is simple: convert cutting-edge research in human biology to products that can replenish the healing environment in everybody. The promise of regenerative medicine is revealing itself every day as research and application grow, but navigating new companies in the market can be hard, especially if they have not kept up with the science or shown a commitment to setting or meeting standards. To fulfill our common vision and more importantly to connect it with patients and clinicians, Predictive Biotech follows an all-encompassing ethos of truth, trust, and transparency. Adhering to the highest standards of product development, product communication, regulatory compliance, and safety. Period.

Allograft Viability

In the emerging field of regenerative medicine, Predictive has set the bar high for processing protocol. The power of our products is in their functionality, but just like all harvested tissue, that functionality can diminish without proper handling. That’s why Predictive processes all of its tissues in its FDA-registered lab utilizing proprietary methods that reduce the loss of important scaffolding proteins, growth factors, cytokines and other properties. Allografts are then cryogenically frozen to better preserve product viability and we even go so far as to provide liquid nitrogen storage containers to our medical partners to ensure the product is kept at -196 degrees. It’s about minimally processing tissue to preserve and share what matters so we can maximize its potential.

Tissue Source & Donor Screening

Wharton’s jelly is a gelatinous substance in the umbilical cord that provides cushioning and support to the umbilical vein and arteries. Also known to be a rich source of cytokines, growth factors, proteins and mesenchymal stem cells. The unique characteristics associated with Wharton’s Jelly have given rise to a wave of new clinical trials to understand its attributes and functions. After extensive research, we believe that Wharton’s Jelly is unparalleled in its potential in regenerative medicine, perhaps offering a way to better the regenerative process for all people.

Aiding the optimal healing environment within the body is the essence of regenerative medicine. And the notion of supplementing what already exists within the body is what makes birthing tissue the ideal source for regenerative products. Specifically, the Wharton’s Jelly layer of the umbilical cord as well as placental tissue. So committed to the potential of these sources, Predictive has invested millions in perfecting the processing techniques necessary to maximize the promise of their regenerative factors. By combining scientific knowledge with proprietary processing we are able to fulfill the demand for consistent, potent human cell and tissue products (HCT/P), and establish higher standards for the field.

All Predictive products are ethically sourced from donated birthing tissues such as umbilical cords and placentas from full-term deliveries. Comprehensive medical and social histories of the donor are obtained and tissues are procured, processed, and tested to exceed standards established by the FDA.

Signature Products

Through rigorous research, Predictive has identified the Wharton’s jelly layer of the umbilical cord, as well as placental tissue to be the richest sources of regenerative properties. It’s from these two sources that Predictive derives our four key products, each containing a unique blend of cytokines, proteins, growth factors and scaffolding properties: the functional factors involved in the reconstruction, repair, and protection of human tissue. Afterall, we think products that cooperate with your body’s natural functions are the best way to help everybody’s body.

 

CoreCyte™ is a minimally manipulated human tissue allograft suspension, derived from the umbilical cord tissue layer of Wharton's Jelly, and processed to maximize mesenchymal stem cell (MSC) concentration. CoreCyte™ contains growth factors, cytokines and over one million viable MSCs (post thaw). CoreCyte™ is the only product on the market with verified MSC counts via third party testing and has demonstrated robust viability in laboratory testing. CoreCyte™ is supplied as a ready to use injectable allograft. 

PolyCyte™ is a minimally manipulated human tissue allograft suspension, derived from Wharton's Jelly, a clear gel-like tissue found in the umbilical cord. The growth factors, cytokines and proteins found in PolyCyte™ are in much higher quantities when compared to similar products derived from amniotic tissues and fluids. PolyCyte™ contains a high concentration of hyaluronic acid which has been shown to increase joint mobility and aid in the reduction of damaging friction within synovial joints. PolyCyte™ is supplied as a ready to use injectable allograft. 

 

AmnioCyte™ is a minimally manipulated human tissue allograft derived from amniotic fluid. Amniotic fluid is a rich source of proteins, cytokines, and growth factors that are required for fetal development and maturation. AmnioCyte™ is biologically similar to synovial fluid in joints and exhibits anti-scarring, anti-adhesion, and anti-inflammatory properties that create an ideal environment to assist in the proliferation and remodeling of damaged tissue via the body's native stem cells. AmnioCyte™ has been widely used as a replacement to corticosteroid injections. AmnioCyte™ is supplied as a ready to use injectable allograft. 

AmnioCyte Plus™ is a minimally manipulated human tissue allograft derived from the extracellular matrix of the amniotic membrane and is intended to supplement or replace damaged or inadequate connective tissue. AmnioCyte Plus™ contains flowable amniotic tissue and serves to help the infiltration, proliferation, and attachment of native reparative cells. AmnioCyte Plus™ contains a high concentration of cellular scaffolding and anti-inflammatory cytokines that aid and enhance the healing process. AmnioCyte Plus™ is supplied as a ready to use injectable allograft. 

CoreCyte™, PolyCyte™, AmnioCyte™ & AmnioCyte Plus™ are processed from donated human tissue from full term deliveries in accordance with FDA guidelines and are 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 Act and are intended for homologous use.

Product Factors

 

Exosome Count By Product

Processing & Safety

 

From donation to administration, Predictive Biotech is unwavering in its commitment to perfecting each and every step. All of our allograft products are prepared utilizing a proprietary mechanical process; two small samples are obtained from each lot with one sent to a third party laboratory for sterility testing and the second used in Predictive's flow cytometer to verify viability and quantify cell populations. After the tissue has been screened for bacterial or viral contamination, processed and aliquoted into the vials, the samples are then cryogenically preserved and placed into quarantine. Once the sterility testing has been completed and all of the paperwork has been reviewed and approved by Predictive's Chief Medical Officer, then--and only then--are our products ready to market.

PBIO-DOC-PRO.OVERVIEW, v1, 8/22/2017

Cryopreservation

One of the many things that separates Predictive Biotech from other regenerative medicine companies is its absolute insistence on best-in-class handling of its products. It’s not enough to package something and send it to market. To truly help everybody we need to do all we can to ensure functionality. That hinges on our cryopreservation system. Not only do we promptly cryogenically freeze our allografts after processing, but we even go the extra step to deliver special Cryotanks to each of our medical partners, complete with instructions for how to maintain it and its contents. This is essential in offering the most promise to all patients using our products.

 

CytoVive®

Transcending The Standard of Care