BioStem’s tissue allografts are processed under validated aseptic conditions. A statistically significant portion of each lot is tested for sterility by a third party CLIA certified laboratory to ensure absence of any bio-burden.

What is perinatal tissue?

Perinatal tissue sources include: Amniotic and Umbilical Cord Tissue.

What is a tissue allograft?

Tissue allografts are defined as the transplant of tissue from one individual to another of the same species with a different genotype.

How long has perinatal tissue been utilized by the medical community?

Perinatal tissue allografts have been successfully used since the early 1900’s as an alternative modality for treatment for chronic wounds. More recently physicians have used these products to treat ocular surface disorders, chronic non-healing diabetic wounds, and in a variety of surgical procedures.

How do these tissue allografts work?

The components work together at the site of the injury to create Local Microenvironment Activation (LMA). Several elements define the niche and regulate stem cell characteristics, such as stromal support cells, gap junctions, soluble factors, extracellular matrix proteins, blood vessels and neural inputs. The LMA is set into action by the paracrine factors released by human amniotic mesenchymal stem cells (MSCs) and their ability to accelerate the wound-healing process by stimulating proliferation and migration of dermal fibroblasts.

How are the tissue allografts stored?

Dehydrated amniotic membrane allografts are stored at ambient temperature.

Have there been any side effects from the use of BioStem tissue allografts?

To date, there have been no serious side effects or adverse reactions from the use of BioStem tissue allografts.

Are the tissue allografts free of contamination?

BioStem’s tissue allografts are processed under validated aseptic conditions. A statistically significant portion of each lot is tested for sterility by a third party CLIA certified laboratory to ensure absence of any bio-burden.