Catalyst Clinicals

Catalyst Clinicals provides amniotic tissue derived allografts minimally manipulated to satisfy HCT/P regulatory requirements. Amnion-Chorion grafts are also available as well as chorion-only grafts to *increase the proportion of therapeutic benefits inherent to placental tissue (*chorion is three times as thick as amnion).

Multiple allograft formats are available to satisfy a range of clinical needs:

  1. Cryopreserved

  2. Dehydrated

  3. Micronized

  4. Fluid

 

Multiple graft sizes available. Catalyst amniotic/placental allografts are available or allografts can be developed & supplied under a third party label with the buyer’s commercial name & specific branding.

 

All allografts are:

  • processed in ISO Class 5 environments

  • regulated by the FDA under 21 CFR 1271

  • produced by a manufacturer registered with the US FDA as a Human Cells Tissues and Cellular and Tissue-based Products establishment (HCT/P) (regulated under section 361 of the Public Health Service Act and Part 1271)

Documented Clinical Benefits of the Use of Amniotic Tissue

  • Immune-privileged

  • Anti-inflammatory: Amniotic tissue has been shown to exert an anti-inflammatory effect by inhibiting the inflammatory cascade. Specifically, it has been shown to inhibit cytokines such as tumor necrosis factor- alpha in the presence of dendritic cells, as well as inhibiting transforming growth factor-beta, interleukin-8, and fibroblast proliferation.

  • Anti-adhesive/antifibrotic

  • Antimicrobial: Amniotic tissue produces β-defensins, which is a major group of antimicrobial peptides that are expressed by epithelial cells and form an integral part of the immune system. They protect epithelial surfaces from microbial colonization.

  • High concentration of growth factors important for healing: Amniotic tissue is comprised of an extracellular matrix, which acts as a natural scaffold for cellular attachment and structural support for cells as well as collagen types I, III, IV, V, and VI, hyaluronic acid, and a host of growth factors.

  • Evidence of stem cell recruitment

  • Analgesic

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