PalinGen is allograft tissue derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of scheduled cesarean section.  Expectant mothers submit their past medical and social history and a detailed risk assessment is performed.  Ultimately, approval of the tissue for use is made by the Medical Director following an intensive and complete medical review and pre-natal evaluation prior to delivery. 

How do amniotic tissue products work?  

 This tissue is rich with the basic components necessary for tissue regeneration including:

  • Growth Factors
  • Cytokines
  • Collagen
  • Fibrinogen
  • Hyaluronic Acid
  • Messenger RNA
  • Mesenchymal stem cells

Amniotic tissues have proven to be multipotent and capable of differentiating into adipogenic, osteogenic, myogenic,endothelial,neurogenic, and hepatic cell lineages. This cellular component may provide an ancillary benefit.

What is amniotic tissue approved for?
           Amniotic tissue qualifies as allograft under21 CFR Part 1271 and section 361 of the Public Health Service Act.  It is minimally manipulated (nothing added).  This means that the FDA recognizes that the properties of amniotic membranes are approved for use as long as the tissues are for homologous use (which is defined as the product performing the same basic function in the donor and in the recipient

What criteria must be met for FDA approval?

  • The tissue be minimally manipulated
  • Must be intended for homologous use
  • Must not be combined with a drug or device
  • Not have a systemic effect and not be dependent on the metabolic activity of living cells for its primary function
  • How long have amniotic tissue based products been used?

Although the popularity in orthopedics and pain management is relatively new, amniotic derived products have a 100 year history of being used in other disciplines for its healing properties.

Is there a chance that bone can grow in the canal or migrate if placed in the gutters, like with what happened with Infuse?
           No, there is no chance of this because the cells are self-signaling.  They will only create or grow what is needed at the site.  If there is a need for bone, then the cells will signal and bone will grow.  If there is a need for vasculature, then the cells will signal for blood vessels to grow and also create tissue regrowth.

What is the best way to characterize this product when speaking with a physician?
It is a multipotent tissue matrix used to fill, cover, and protect, a void or defect.

 How does amniotic tissue differ from PRP?
            PRP (platelet rich plasma) is venous blood that is centrifuged to separate the buffy coat which contains the PRP. The product is used on the same patient as autologous tissue. The liquid material contains some growth factors but the potential for healthyMSCs is limited for the following reasons:

  • Patient age
  • Mechanical degradation in centrifuge
  • Patient medical history

PRP injections are used readily in the orthopedic, pain management and sports medicine practices.  PRP has been highly publicized with high profile athletes receiving injections. From a marketing standpoint, this has a lot to do with PRP’s recent success.

How does amniotic tissue differ from bone marrow derived products?
           Bone marrow derived products come from recently deceased donors. Two big challenges in the recovery of healthy tissue are the donor's age as well as the time of death to recovery. Both have negative consequences on the health of the allograft in general.
           The difference between our product and those that require harvest from Adipose Tissue or Bone Marrow. We do not advertise that we are a stem cell product, we are a nutritional regenerative soup that contains growth factors, cytokines, fibroblasts,keratinocytes, and MSC's derived from human fetal tissue, we are a human transplant allograft. It is the power of the balanced growth factors that allow our Flow product to be so effective and safe, additionally it is minimally manipulated so that we do not add anything that can cause a reaction as described in attached article.

           There is a huge difference in the literature between the types of cells we utilize and those that are obtained form autologous harvest and then concentrated and cultured.

 How does PalinGen differ from Cortisone Therapy?
           Cortisone is anti inflammatory, that has no randomized controlled studies, it has over 100 potential side effects. It has the potential to cause tendon rupture, muscle and tissue atrophy, increase glucose levels to name a few side effects. That is why it is limited to 3 injections in any one anatomic area. PalinGen is a potent anti-inflammatory, regenerative cell based therapy, with no side effects, can be used as often as necessary with no maximum dose.

How do PalinGen products compare to other products claiming to contain a cellular component?
           The amount of MSCs in adults declines with age.   We cannot cite a specific number or claim to have MSC s in the PalinGen products. However it has been proven that generally, the younger the tissue, the more viable cells exist.

How does Amniotic tissue work in wound care?
           Amniotic tissue has been used in wound care and is highly effective in both promoting re-epithelialization and suppressing inflammation. Amniotic tissue provides a new basement membrane that helps in the migration of epithelial cells, reinforces adhesion of basal epithelial cells, promotes epithelial differentiation and prevents epithelial breakdown. It also down-regulates TGF-beta signaling, responsible for fibroblastic activation in wound healing. This inhibits fibroblast proliferation and prevents fibrosis.

Why is there no chance of rejection?
           Amniotic membrane does not express HLA-A, -B or -DR antigens. The chorion which has been known to cause an antigen response, has been removed from the tissue at processing.

 What growth factors are present in the Amniotic Membrane products?  How do they work?
           The amniotic membrane serves to protect the embryo in utero and possesses many different growth factors that serve to protect the developing fetus.  These growth factors regulate a host of different physiologic functions which contribute to cell proliferation, cell migration, and cell growth. Additionally, Amniotic tissue contains collagen substrates, the full range of growth factors, amino acids, carbohydrates, cytokines, hyaluronic acid, fibroblasts, epithelial cells, extra cellular matrix, micronized amniotic membrane and mesenchymal stem cells.

What are some clinical uses of the injectable product that have had success?

  • Plantar fasciitis
  • Epicondylitis
  • Tendonitis (biceps, triceps)
  • Tendinosis
  • Acromioclavicular joint inflammation
  • Facet osteoarthritis
  • ACL Tears
  • MCL Tears
  • Post-operative pain (orthopedic surgeries and spine)
  • Wound healing

Is the injectable product reimbursed and in what clinical setting?
           When submitted for reimbursement correctly, there has been success in reimbursement. However, all payors are different and each case is unique. The greatest opportunity for reimbursement occurs when the product is used in an operating room or surgical center under ultrasound guidance or other imaging assistance.

What is the cost of amniotic allograft?
           PalinGen and the family of amniotic products are priced competitively and fall in line with other osteopromotive materials. However, it is believed that amniotic tissue is a more robust, better quality allograft.  Most insurances do not cover this type of treatment because it is not a mainstream therapy, but if you have an HSA or HRA, they can be submitted to insurance.  Most importantly, the therapy is affordable and has great success at getting people back to their old lives before the disability and pain began.  Contact the office to schedule a time to discuss your particular problem.

Quality Care

Friendly Faces

PalinGen Regenerative Therapy

(Unfortunately, at this time, we are unable to provide this service due to insufficient staff trained for such a procedure. Though, we do plan to make it available again soon!)