FlōGraft® – A Flowable Human Allograft
A Flowable Human Allograft

 A Flowable, Cryopreserved, Human Allograft
Chorion-free amniotic tissue & fluid

Amniotic Membrane & Fluid: A Biologic System

DSC_2048.jpgFlōGraft® is chorion-free allograft comprised of amnion and amniotic fluid derived from prescreened, live, healthy donors. Amniotic membrane and fluid act as a biologic system that ensures symmetrical structure development and growth; cushions and protects the embryo; has a significant defensive role as a part of the innate immune system, and protects the fetus by maintaining consistent pressure and temperature. FlōGraft® retains this protective function as a versatile and manageable liquid allograft and is indicated as an additive in a number of general surgical applications including soft tissue defects, soft tissue trauma, tendinitis, tendinosis, chronic wounds, and localized inflammation.

Product Detail – BioSurgery

Chorion-Free Allograft and Immune Privilege

The placental organ is carefully processed to remove the chorion layer, which may produce an immune response in recipients who are not compatible with the donor’s blood type.  FlōGraft™ contains only amniotic tissue; amnion surface epithelial cells do not express HLA- A, -B, -C, or -DR or b2-microglobulin and have led to the characterization of the placental organ as “immune privileged” as published in numerous scientific journals. (1,2)

Amniotic Membrane

FlōGraft®  is carefully processed to preserve the structural qualities of the amniotic membrane yet allow for the allograft to implanted using a 22g-23g needle. Amnion is a native source of collagen types III, IV, V, and VII, as well as and fibronectin and laminin. It also contains fibroblasts and growth factors, modulates, cytokine and growth factor levels, and has been shown to have unique properties, including the ability to suppress pain, fibrosis, and bacteria and to promote wound healing.(3-6) These qualities may provide an ancillary benefit to the primary purpose of FlōGraft® human allograft as a soft tissue defect filler.

Amniotic Fluid As The Suspension Mechanism

Amniotic fluid contains nutrients and growth factors that facilitate fetal growth and provides mechanical cushioning and antimicrobial properties that protect the fetus. Amniotic fluid also contains carbohydrates, proteins and peptides, lipids, lactate, pyruvate, electrolytes, enzymes, hormones, epidermal growth factor, amnion-derived stem cell, transforming growth factor (TGF)-a, TGF-b1, and fibroblast growth factor (FGF), hyaluronic acid, amnion epithelial cells, derived from the embryonic ectoderm, and amnion mesenchymal cells. It should be noted that the presence of the referenced native organic components may provide an ancillary benefit to FloGraft’s primary purpose as a soft tissue defect filler.

Human amniotic membrane proved to be a versatile and useful temporary biologic dressing in studies involving [hundreds of patients for nearly 100 years.] Wounds, both traumatic and nontraumatic in origin, responded to a protocol that allowed coverage of tissues as diverse as exposed bowel, pleura, pericardium, blood vessels, tendon, nerve and bone…Wounds unresponsive to usual therapeutic measures responded to membrane application. Human amniotic membrane dressings are therefore a useful adjunct in the care of the complicated wound.(7)

ALLOGRAFT CHARACTERISTICS

CRYOPRESERVATION – THE GOLD STANDARD

FlōGraft® is cryopreserved and stored at –65C or colder to most completely preserve the allograft native structure. Additional procedure time required for the implant of FlōGraft® is nominal. From the removal from the shipping container or ultra-cold freezer to final implant. The  entire procedure, from ultra-cold storage removal to final implant, takes only a few minutes.

CHORION-FREE ALLOGRAFT AND IMMUNE PRIVILEGE

DSC_2814(1).jpgThe placental organ is carefully processed to remove the chorion layer, which may produce an immune response in recipients who are not compatible with the donor’s tissue type.  FlōGraft® contains only amniotic tissue; amnion surface epithelial cells do not express HLA- A, -B, -C, or -DR or β2-microglobulin; amnion has been used successfully as a skin graft without concern for tissue typing and matching of the donor to the host and have led to the characterization of the placental organ as “immune privileged” as published in numerous scientific journals. (8,9)

FLŌGRAFT®  – A NATURAL COLLAGEN SCAFFOLD

Amniotic membrane is a known source of interstitial collagens (types I, II, III) and filamentous collagens type V and VI, the structure of which is well-preserved during processing and preservation of the amniotic membrane.

Safety Testing

FlōGraft® Product Size

  • 0.25cc
  • 0.50cc
  • 1.00cc
  • 2.00cc

 

Reference

  1. Akle CA, Adinolfi M, Welsh KI. Immunogenicity of human amniotic epithelial cells after transplantation into volunteers. Lancet 2:1003–1005, 1981.
  2. Solomon A, Wajngarten M, Alviano F, Anteby I, Elchalal U, Pe’er J, Levi-Schaffer F. Suppression of inflammatory and fibrotic responses in an in-vitro model of allergic inflammation by the amniotic membrane stromal matrix. Clin Exp Allergy 35:941–
    948, 2005.
  3. Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A. Clarification of the nomenclature for MSC: the International Society for Cellular Therapy position statement. Cytotherapy 7:393–395, 2005.
  4. Modesti A, Scarpa S, D’Orazi G, Simonelli L, Caramia FG. Localization of type IV and V collagens in the stroma of human amnion. Progr Clin Biol Res 296:459–463, 1989.
  5. Fukuda K, Chikama T, Nakamura M, Nishida T. Differential distribution of subchains of the basement membrane components type IV collagen and laminin among the amniotic membrane, cornea, and conjunctiva. Cornea 18:73–79, 1999.
  6. Koizumi NJ, Inatomi TJ, Sotozono CJ, Fullwood NJ, Quantock AJ, Kinoshita S. Growth factor mRNA and protein in preserved human amniotic membrane. Curr, Eye Res 20:173–177, 2000.
  7. Joseph S. Gruss, et al., Human amniotic membrane: a versatile wound dressing, CMA JOURNAL/MAY 20, VOL. 118, p. 1237 (1978)
  8. Akle CA, Adinolfi M, Welsh KI. Immunogenicity of human amniotic epithelial cells after transplantation into volunteers. Lancet 2:1003–1005, 1981.
  9. Solomon A, Wajngarten M, Alviano F, Anteby I, Elchalal U, Pe’er J, Levi-Schaffer F. Suppression of inflammatory and fibrotic responses in an in-vitro model of allergic inflammation by the amniotic membrane stromal matrix. Clin Exp Allergy 35:941–948, 2005.