FAQs

The term refers to surgical procedures that include regenerative biologic augmentation with materials that include stem cells, growth factors, cytokines, etc. The usage of the regenerative materials assists with more complete and faster healing, less scar tissue, increased blood flow to the area, reduced complications and improved outcomes

An increasing number of studies is showing the improved outcomes for surgery of the knee, shoulder and spine. With the materials being extremely low risk, having no ethical issues and assisting dramatically with outcomes, in medicine that is called a HOME RUN!

The answer is yes. While the surgeries are covered by insurance, our affiliated surgery centers are currently unable to accept Medicaid and some HMO plans.

We are able to accept commercial payers, Medicare, Worker’s Compensation and Personal Injury Liens!

Undergoing surgery for your knee, spine or shoulder is not a decision to be taken lightly. Some of the reasons for concern include lengthy rehab, surgical failure, potential complications and need for a revision procedure.

The addition of regenerative biologics helps turn a hostile non-healing surgical environment into one that contains stem cells, growth factors, cytokines and more. This facilitates healing with increased blood flow and helping your own body heal the wound better than it would conventionally.

The biologic material reduces scar tissue, increases blood flow, and enhances the soft tissue to bone integration. This helps with short term and long term healing.

The Stem Cell Assisted Surgery^TM Certified Centers focus on surgery of the spine, knee and shoulder. Visit each body area’s specific page to learn more about the procedures included.

Stem Cell Assisted Surgery^TM Certified Centers focus on regenerative materials obtained from the “products of conception”. These include:

• Amniotic Fluid
• Placental Membrane
• Umbilical Cord Tissue
• Umbilical Cord Blood
• Wharton’s Jelly

These “products of conception” are full of growth factors, cytokines, stem cells, exosomes, secretomes and more which are instrumental in facilitating healing. There are no ethical concerns, no babies are harmed, no embryonic stem cells are used, and the FDA strictly regulates the materials.

Any surgical procedure may entail complications ranging from anesthesia complication to infection, nerve injury, bleeding, scar tissue, failure to heal, etc.

• • When it comes to the regenerative biologics, they are very safe. Here are some bullet points on safety.

• • Studies have shown that bone marrow aspiration procedures have a high incidence of complications. Twenty nine percent of patients end up with chronic pain, which is a real problem when the objective is to actually rid patients of pain. Can you imagine that conversation, “Hey doc my knee feels awesome but what did YOU DO TO MY HIP!”

• • Additional complications reported from bone marrow aspirations include infection, bleeding, nerve/vessel injury, bowel perforation, pelvic fracture.

• • The mini-liposuction procedure does not have a high incidence of complications. However, as mentioned, most of the stem cells from that procedure die within 48 hours. Real bummer.

• • On the other hand, all of these issues are avoided by not having to use a harvesting procedure.

• • In addition, the amniotic fluid does not have HLA factors in sufficient quantity to cause a rejection in the recipient. Also known as MHC factors, these are the cell components that would lead to a Graft versus Host reaction if they were present in sufficient concentrations. The amniotic fluid is immunologically privileged as a result.

• The umbilical cord tissue/blood material could cause a rejection reaction if not treated properly. As an example, if one receives a blood transfusion from an incompatible donor the blood will be rejected with a potentially very serious reaction. To prevent that from happening, all red blood cells are removed from the umbilical cord blood. This removes the HLA factors and prevents the Graft versus Host reaction.

They are not regulated as drugs, rather they fall into the biologics category. These are regulated heavily by the FDA, but do not get approved or denied.

Here is how the FDA regulates things:

1. Medical devices – joint implants, screws/rods, DME, etc. In the world of regenerative medicine, this only applies to the kits used in PRP, bone marrow or adipose procedures.
2. Drugs – think of Lipitor, Vicodin, Viagra, etc. These are medications that have gone through a clinical trial and been approved for a specific indication.
3. Biologics – the FDA strictly regulates how biologic materials are acquired, processed, stored and used under the CFR Part 1271. Amniotic and umbilical materials fall under this category, which does not involve an Approval/Denial process like drugs do.
   1. Specifically, the section under Part 1271 that applies to amniotic/umbilical tissues is Section 361 products, which are not required to be licensed or approved by the FDA and are regulated under Section 361 of the Public Health Service (PHS) Act.

No there are not. None of the biologic materials come from “aborted fetuses”. During the biologic acquisition, the babies are fine and the material donated and used is normally discarded.

In addition, no embryonic stem cells are used in the US anymore legally. There is no fetal tissue, no cloning and all donors are consented and screened according to FDA regulations.

So what this means is there are NO ethical concerns with the materials being used from the products of conception.