11496 Luna Rd Ste 800, Dallas, TX 75234

We’re open Monday – Friday, 8:00 AM – 5:00 PM CST

We’re also available via phone and email

Email: info@signaturebiologics.com

Phone: 972-807-5916

Frequently Asked Questions

What is Signature Biologics?

Signature Biologics is a biotechnology company specializing in the production of placental derived products under Section 361 of the Public Health
Service Act according to 21 CFR Part 1271.10.

What is in the Products?

Signature Matrix is derived from the amniotic membrane and contains hexagon shaped 1.5mm pieces of tissue. The amount of tissue ranges depending on the concentration ordered. A 2x product contains 300 μls of our proprietary solution which contains about 20% tissue. The Matrix
can fit through a 20 gauge or larger needle.

Signature Cord is derived from umbilical cord tissue. A 2x product contains 75 mgs of tissue/ mL. Signature Cord can pass through a 20 gauge needle with plans to expand our product portfolio to include variations that can traverse a 32 gauge needle.

Both products contain 10% DMSO in the final product.

Is it FDA Approved?

The manufacturing lab is registered with the FDA. Our products do not require the traditional FDA drug approval. Our products are exempt from
the formal FDA drug approval process and are regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 The exemption criteria is set
out in 21 CFR1271.10(a).

What is special about allograft products derived from perinatal tissue?

Perinatal tissue has a variety of growth factors, cytokines, and mesenchymal stem cells. They have a robust induction of vascular
conduction systems (angiogenic properties).

What is the chain of custody for tissue used in our products?

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 through Signature Biologics.

How is the product regulated / what category of product(s) is this?

Our biologics products are under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10.

Does your product have live cells?

The original tissue has live cells inside it and we strive to maintain the integrity of the raw material. Our product is not based around the metabolic
activity of these cells, any cells are simply a component of the tissue.

Do you have quality control materials / release criteria?

Yes, our basic criteria are absence of bioburden and donor eligibility determined by our Medical Director. We also have a variety of internal control criteria. Each final product is also standardized by volume of tissue.

How does the product work in terms of patient outcomes / pain?

Our product retains the powerful original relevant characteristics of the umbilical cord/amnion tissue, maintaining the tissue’s regenerative utility
for repair and reconstruction. The product works as a cushioning and protection agent.

How is the product made?

Donations are received only from full-term, healthy c-section births. Donors are screened for all communicable diseases. Only fresh tissue (48 hour recovery window) is used and processed using our proprietary ‘Signature Process’. This process includes decontaminating
incoming tissue and sending out samples from each final lot to a third party lab to test for sterility. At the end of the process the product
vials are cooled using a slow rate freezing method and stored at -80°C. Product is stored in
quarantine until sterility testing has been approved and internal release criteria has been tested for. Each lot is uniquely identified and tracked to usage by patient.

What are the downsides / adverse reactions of the product?

It is quite uncommon for patients to experience any significant side effects stemming from treatments with our products, but, as with any medical procedure, there is the possibility that a patient might experience certain side effects after undergoing treatment.

Is the product inhibited by other medications or treatments?

It is possible that the efficacy of our products may be inhibited if patients are taking other medications or are currently undergoing some
other type of medical treatment. During the initial consultation process, the patient should take great care to disclose any medications they
are taking and any treatments they are undergoing so that the doctor can determine the patient’s eligibility for treatment. Patients taking
blood thinners or those with an active infection, for example, could be excluded from treatment under certain circumstances.

Is the product immune evasive?

Amniotic membrane and umbilical cord tissue is naturally immune evasive.

Is the product sterile?

Our products 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) is not sterile but has been validated to ensure it keeps the sterility of its contents. The external container should not be introduced into a sterile field. More information can be found in the package insert.

What is the injection protocol like?

The injection site should be sterilized. Any medical protocol is physician determined; we recommend peer to peer inquiries to learn more.

How long does it take the product to start working / what is the time period in which patients can see gains?

There are a wide variety of factors that can influence treatment responses. Most people will notice any gains within a couple of weeks after a procedure.

What is the proof of concept of these products / results?

Tens of thousands of patients have utilized umbilical cord tissue allografts and amnion tissue allografts. Dr. Ruben Berrocal Timmons (Berrocal et al, Current Trends in Biotechnology and Pharmacy 2018) has published a paper in the journal Current Trends in Biotechnology and Pharmacy which utilized our tissue product.

How are orders placed?

Orders should be place via emailing an order form to info@signaturebiologics.com.

How is the product shipped?

The product is shipped overnight on dry ice.

How is the product stored?

The product should be kept stored at a minimum of -65 degrees and thawed prior to use. Thawing instructions can be found in the package insert.

Is the product covered by insurance?

Most insurance agents consider this treatment an investigational therapy and are therefore unlikely to cover the costs of the biologics product. Some private insurers are beginning to integrate these offerings into their plans. When considering any medical procedure, patients should always consult their insurance provider to find out what is covered by insurance and what is not. As more research studies become available and demonstrate efficacy, it is expected that more and more insurance carriers will begin to cover the costs associated with stem cell treatment. Fortunately, patients will often find that these treatments are quite affordable even in the absence of insurance coverage.

Do you have any samples?

We currently do no offer samples.

What is the difference between embryonic and adult stem cells?

Embryonic stem cells are pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo. Embryonic stem cells have the ability to divide indefinitely and become any type of cell in the body (pluripotent), therefore researchers saw them as a panacea for the treatment of many diseases. The reality is that they are notoriously difficult to control and tend to form tumors. Adult stem cells are any stem cells derived from a postnatal source, which includes the umbilical cord, adipose and bone marrow sources.

How can stem cells promote healing?

Stem cells are like building blocks that can be encouraged to form into new, healthy tissues to replace diseased or injured cells, such as growing new knee cartilage, or helping to speed healing in various areas of the body. Normally, adult stem cells are present, but not activated. Known as progenitor cells, adult stem cells remain dormant until required. Presently, it is not clear if the cells change into the necessary type of cell or if they simply start and or encourage the healing cascade, but we do know that they carry reparative capabilities that can be used to promote healing at a cellular level.

What are autologous / homologous stem cells?

There are several distinct methods through which stem cells can be collected before being deployed during the treatment process, and these methods might involve the use of either homologous or autologous stem cells. Homologous stem cells are stem cells collected from a source other than the patient undergoing treatment, while autologous stem cells are harvested directly from the patient. Stem cells taken from a matching donor would thus be considered homologous.

How do stem cells work?

Essentially, stem cells are progenitor cells which are capable of regeneration and differentiation into a wide range of specialized cell types. Once injected, stem cells follow inflammatory signals from damaged tissues and have multiple ways of repairing these damaged areas. Mesenchymal stem cells (MSCs) used in Panama are considered to be multipotent (they can transform into different cell types but cannot form an organ) but not pluripotent. In the body, these cells Do NOT function by transforming into different cell types or tissues. They act via anti-inflammatory activity, immune modulating capacity, and the ability to stimulate regeneration. If you would like to learn more about treatments with MSCs, we recommend reading Dr. Riordan’s book: https://www.amazon.com/Stem-Cell-Therapy-Disrupting-Transforming-ebook/dp/B071GRNQPX

What is the difference between what is available outside of the country versus within the United States?

The single biggest hurdle faced in cell therapy and the perinatal tissue product market is technical. The manufacture of cell therapy biologics and perinatal tissue products has layers of complexity that are absent from other therapies. Regulations vary based upon jurisdiction. For example, with the current regulatory environment in the United States, there are strict
restrictions on the isolation and expansion of cells. Within the United States, pure MSC products are not able to be give to patients as no pure MSC cell product has been approved by the FDA at this time. With the existing regulatory environment, these pure MSC preparations are able to be given at our facility in Panama. Within the regenerative medicine market in the United States, we have utilized what we have learned over the past 12 years in Panama to create 361 compliant perinatal tissue products. Defining and testing the quality of cell therapy products and perinatal tissue products is of utmost importance. The US regulatory market is experiencing some exciting transitions that can start expanding citizen’s access to new regenerate products and treatment plans. This includes the federal Right to Try law and on a local level Texas’ House Bill.