Patient Information

An advancement in regenerative medicine, the Amnio Technology line of products are made from human amniotic membrane and fluid. These amniotic tissues, or allografts, are transplanted to provide protection and support for native tissues in the body.

The amniotic membrane is the innermost layer of the placenta which nourishes and maintains an unborn child. Amniotic fluid is the liquid that surrounds the baby until delivery. Just as these tissues provide biologic and physiologic properties and act as a physical barrier to cover and protect the fetus during pregnancy, the Amnio Technology line of products provides a biological, physiological and physical overlay to support and protect an injury in the body.

Amniotic tissues contain a unique mix of bioactive substances such as collagen, adhesion molecules and growth factors recognized as important in the wound healing process¹. Published studies on the benefits and efficacy of amniotic tissue in wounds date back over 100 years².

Amniotic tissue has reported anti-inflammatory, anti-bacterial and anti-fibrotic properties3,4. Amniotic tissues are also thought to have “immune privilege”, reducing the risk of an adverse immune reaction5.

All of these characteristics make amniotic allografts an attractive wound biomaterial.
 

Where do the tissues come from?

Amnio Technology products do not require fetal sacrifice and recovery is performed with maternal consent during live birth. Placental tissues are collected at several facilities around the country, following strict guidelines and consistent with industry best practices.
Donors are healthy women between the ages of 18-45 years. A careful medical and social history is collected in advance to ensure mothers meet all eligibility requirements. Donors are thoroughly screened for communicable diseases.

At the time of Cesarean delivery (also known as C-section), the baby is delivered and the placenta and fluid, which are typically discarded, are saved. All tissues are then tested to ensure viability and safety.

Tissues are processed at Pinnacle Transplant Technologies, LLC in accordance with cGTP, and allografts are subjected to stringent USP testing prior to release.
 

What are the product risks?

PalinGen® products may not provide an improvement in your condition or injury. There is a possibility of an adverse immune reaction.

This is not a complete list of risks. Discuss the potential risks and benefits of product use with your doctor or health professional.
 

References:

  1. Complements and the Wound Healing Cascade: An Updated Review. Hani Sinno and Satya Prakash. Plast Surg Int. 2013; 2013: 146764
  2. The Grafting of Preserved Amniotic Membrane to Burned and Ulcerated Surfaces, Substituting Skin Grafts: A Preliminary Report. Maximilian Stern. JAMA. 1913; 60(13): 973-974
  3. Amniotic Fluid: Not Just Fetal Urine Anymore. Mark A Underwood, William M Gilbert, Michael P Sherman. Journal of Perinatology. 2005; 25:341-348
  4. Growth factors and cytokines in wound healing. Barrientos S, Stojadinovic O, Golinko MS, Brem H, Tomic-Canic M. Wound Repair Regen. 2008; 16(5): 585-601
  5. Immunological characteristics of amniotic epithelium. Hori J, Wang M, Kamiya K, TakahashiH, Sakuragawa N. Cornea. 2006; 25(10): S53-58