PalinGen

PALINGEN AMNIOTIC INJECTIONS PROVIDE RELIEF FROM KNEE, HIP, & SHOULDER PAIN. AVOID SURGERY.

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WHAT ARE PALINGEN® AND PALINGEN® FLOW?

PalinGen® and PalinGen® Flow are innovative new ways of helping patients with chronic knee pain, hip issues, degenerative disc disease, shoulder arthritis, and various orthopedic joint problems through a process called stem cell recruitment. They work via amniotic injections and are considered a "same day treatment." Along with stem cell recruitment (stem cell amniotic fluid injection to promote healthy new growth in damaged areas) and Zilretta (slow-release no-opioid pain medication for knee pain), PalinGen® can be a key component in treatments for pain relief.

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Palingen-InovoFlo

PROCESSED AMNIOTIC FLUID

PalinGen®, Regenerative Medicine, and Amniotic Fluid

An advancement in regenerative medicine utilizing minimally manipulated amniotic fluid, PalinGen® InovoFlo™ is a human allograft comprised of amniotic fluid components. PalinGen® is ntended for homologous use to supplement tissue for protection, cushioning and lubrication.

Why Does PalinGen® Use Amniotic Fluid?

Amniotic fluid functions as a supportive cushion to the fetus and provides a protective environment including rich sources of nutrients, cytokines and growth factors that are required for fetal development and maturation. Amniotic fluid possesses anti-inflammatory, anti-microbial and regenerative properties that make it, and thus PalinGen,  attractive for use in clinical application

Do You Find Yourself Asking These Types Of Questions?

"My pain is always on, I need a pain medication that lasts without thinking about it."

"Why can't I even perform everyday chores and tasks without pain?"

"The simplest activities are even truly painful. When does it stop?"

"I have Type 2 diabetes and I am worried about my osteoarthritis treatment elevating my blood glucose level."

"I am ready for a new treatment option."

ARE YOU DIRECTLY AFFECTED BY ORTHOPEDIC JOINT PROBLEMS OR OSTEOARTHRITIS?

Fill out the form at the top of this page to see if you qualify! Or use the button below to find a local provider.

Or Call   (847) 243-6041

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FREQUENTLY ASKED QUESTIONS

WHAT IS PALINGEN?

PalinGen is allograft tissue derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of scheduled Caesarian section.  Expectant mothers submit their past medical and social history and a detailed risk assessment is performed.  Ultimately, approval of the tissue for use in PalinGen 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 and ancillary benefit.

WHAT IS AMNIOTIC TISSUE APPROVED FOR?

Amniotic tissue qualifies as allograft under 21 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. This, of course, is the case with PalinGen.

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

PalinGen meets all the criteria.

HOW LONG HAVE AMNIOTIC TISSUE BASED PRODUCTS BEEN USED?

Although the popularity in orthopedics and pain management is relatively new, amniotic derived products like PalinGen 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?

PalinGen is a multi potent 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 healthy Mesenchymal stem cells 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 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 PalinGen product and those that require harvest from Adipose or Bone Marrow. is that we do not advertise that we are a stem cell product. PalinGen is a nutritional regenerative soup that contains growth factors, cytokines, fibroblasts, keratinocytes, and Mesenchymal stem cells derived from human fetal tissue, PalinGen is 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 PalinGen utilizes and those that are obtained from autologous harvest and then concentrated and cultured.

HOW DOES PALINGEN DIFFER FROM CORTISONE THERAPY?

Cortisone is an anti-inflammatory that has no randomized controlled studies but does have 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. PalinGen 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 Mesenchymal stem cells in adults’ declines with age.   We cannot cite a specific number of Mesenchymal stem cells guaranteed to be present in 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 WITH PALINGEN?

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 and thus is not present in PalinGen.

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)

IS THE INJECTABLE PRODUCT REIMBURSED AND IN WHAT CLINICAL SETTING?

When PalinGen claims are 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 PalinGen 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 its 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.

Allograft tissue is derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of scheduled Caesarean 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.

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MEMORIES WITH FRIENDS

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MEMORIES DOING THE THINGS YOU LOVE TO DO!

MEMORIES DOING THE THINGS YOU LOVE TO DO!

FIND A LOCAL PROVIDER

Fill out the form to find a local provider near you. We also provide a helpful symptom summary form to bring in to your provider if you want treatment.

PalinGen and PalnGen Flow is a registered trademark of Amnio Technology, LLC