HCP FAQ

General Questions

What is special about perinatal tissue?

The human fetus is capable of regenerative and scarless healing. If correctly processed, perinatal tissue has been shown to retain these regenerative properties and can effectively be applied to unrelated hosts through allografts, or human-to-human tissue transfers.

These tissue allografts are immuno camouflaged (lack HLA) to protect the child from the mother’s immune system during gestation. They are also naturally rich in growth factors, cytokines, extracellular matrix and more.

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, Achilles tendinitis, plantar fasciitis, pain management, osteoarthritic conditions, sports injuries, in a variety of surgical procedures, and in treating neuropathic pain.

How do these 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 these allografts stored?

Flowable amniotic tissue allografts are cryopreserved and stored below -80° C.
Flowable umbilical cord tissue allografts are cryopreserved and stored on liquid nitrogen below -150° C.
Amniotic fluid allografts are terminally sterilized and stored between 2° C and 10° C.
Dehydrated amniotic membrane allografts are stored at ambient temperature.

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

To date, there have been no serious side effects or adverse reactions from the use of BioStem allografts. Not withstanding its safety history, any adverse events should be reported to your physicians and BioStem.

Quality

How does the FDA regulate the use of amniotic tissue and fluid?

Perinatal tissue is regulated by the Food and Drug Administration (FDA) under Section 361 of the Public Health Safety Act (PHSA), Code for Federal Regulation (CFR) 1271.3 and 1271.10 as minimally manipulated tissue allograft www.fda.gov (Regulation of Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/P’s)

Do you have quality control materials / release criteria?

BioStem Technologies follows strict quality control guidelines in donor eligibility, tissue handling, transmittable disease screening, bio-burden reduction and end-to-end traceability. All product is quarantined until third party testing is completed for release and eligibility is approved by our Medical Director.

What is the chain of custody for BioStem's tissue allografts?

Our tissue is acquired from licensed third parties whom specialize in tissue acquisition. Once tissue is received the processing, storage, and distribution is all handled within the BioStem's Quality Management System.

Are the allografts free of contamination?

BioStem's 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. The external container (vial) has been validated to ensure it keeps the sterility of its contents. The vial is then stored in a sterile sealed pouch as a secondary barrier. More information can be found on the product IFU.

Do your allografts have live cells?

We strive to maintain the integrity of the raw material, this allows preservation of the original tissue structural components and viability.

Billing and Shipping

Are perinatal allografts covered by commercial insurance?

Some commercial insurance providers will provide coverage for human amniotic membrane when it is determined to be medically necessary because the medical criteria and guidelines have been met.

How are the allografts shipped?

The flowable allografts are shipped on dry ice for next day delivery.
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The two available shipping methods are as follows:

1) FedEx Priority Overnight (Between 10:30 AM and 12:00 PM Delivery, depending on your distance from the local FedEx Center)
2) FedEx First Overnight (08:00 AM Delivery)

*Extra Dry Ice Available Upon Request.

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