Table 4

Summary of 10 commonly utilized amnion-derived biologic agents used in orthopedics.

Product (Company)CompositionGrowth FactorsProcessingStorageShelf LifeAvailable ConfigurationsProposed Effects and Uses
Affinity (Organogenesis); Canton, MA, USAFresh amniotic membraneNLNLRefrigeratorNLLiquid

  • Tendon repair

  • Cartilage and osteochondral defect repair

  • Wound healing

  • Protective barrier formation

Allogen (ViVex); Atlanta, GA, USAFrozen allograft derived from amniotic fluidTIMP-2, HGF, IL-6, TIMP-1, IL-1ra, GRO-a, TGF-B1, TGF-B2, TIMP-4NLAmbient conditions, refrigerator, or frozen2 y at −40°C for frozen configuration and 2 y at 2–30°C in liquid configuration

  • AlloGen: frozen

  • AlloGen liquid

  • Joint cushioning and preservation

  • Wound healing

  • Skin regeneration

AlloWrap DS (Allosource); Centennial, CO, USAAmniotic membraneTGF-B1-B3, TGF-A, EGF, KGF, HGF, bFGF, IL-1, IL-2, IL-10, MMP-1–4NLAmbient conditions2 y

  • Sheet/membrane

  • Decrease scar and adhesion formation

  • Anti-inflammatory

Amniofix (MiMedx Group Inc); Marietta, GA, USAAmniotic tissue membrane compositeEGF, KGF, HA, IL-6PURION processa Ambient conditions5 y

  • Sheet/membrane

  • Wrap

  • Particulate

  • Reduce postsurgical scar formation

  • Anti-inflammatory

  • Enhances soft tissue healing

  • Barrier for scar formation

  • Surgical, neurologic, soft tissue, and tendon applications

Clarix Surgical Matrix (Amniox Medical Inc); Miami, FL, USACryopreserved human amniotic membraneEGF, KGF, HA, IL-6CRYOTEK processb Refrigerator or freezer3 mo at 1–10°C; 1 y at −49 to 0°C; 2 y at −85 to −50°C

  • Sheet/membrane

  • Particulate

  • Surgical covering/barrier

  • Modulates wound environment to reduce scar formation

FloGraft (Applied Biologics); Scottsdale, AZ, USAAmnion and amniotic fluidNLNLRefrigerator or freezerNLLiquid

  • Soft tissue trauma

  • Tendinitis/tendinosis

  • Wound healing

  • Anti-inflammatory

  • Muscle, ligament, and tendon strains or partial tears

NuCel (Organogenesis); Canton, MA, USAAmnion and amniotic fluidNLNLNLNLLiquid

  • Promotion of tissue growth and healing

  • Inhibits scar formation

  • Anti-inflammatory

PalinGen Flow/Sports Flow (Amnio Technology); Phoenix, AZ, USAAmnion and amniotic fluid componentsFGF, EGF, PDGF A and B, VEGF, TGFβNLFreezerNLLiquid

  • Anti-inflammatory

  • Improved wound healing

  • Decreased scar formation

ReNu (Organogenesis); Canton, MA, USACryopreserved amniotic suspension allograftNLNLFreezerNLLiquid

  • Soft tissue healing

  • Knee osteoarthritis

  • Anti-inflammatory

ViaShield (Globus Medical); Audubon, PA, USAChorion-free, dual-layer amnion patchNLNLNLNLSheet/membraneNL

  • Abbreviations: bFGF, basic fibroblast growth factor; EGF, epidermal growth factor; GRO, growth regulated protein alpha; HA, hyaluronic acid; HGF, hepatocyte growth factor; HGF, hepatocyte growth factor; IL, interleukin; KGF, keratinocyte growth factor; MMP, matrix matalloproteinase; NL, not listed; PDGF A and B, platelet derived growth factor alpha and beta; TGF, transforming growth factor; TIMP-2, tissue inhibitor of metalloproteinases 2; VEGF, vascular endothelial growth factor.

  • ↵a The PURION process of cleaning, dehydration, and sterilization safely and carefully separates placental tissues, cleans and reassembles layers, and subsequently dehydrates the tissue to preserve the key elements associated with healing. The amniotic membrane scaffolding is protected while blood components are removed, so an intact extracellular matrix is left behind. No chemical cross-linking or decellularization occurs during the process.

  • ↵b The CRYOTEK process uses cryopreservation (deep freezing) to maintain the innate biological and structural integrity of the natural tissue while maintaining its natural hydrated state.