RHEO™

Flowable Cryopreserved Human Amniotic Fluid Allograft With Extracellular Matrix

RHEO™ is a connective tissue allograft flowable matrix that is derived from chorion-free human placental tissue and amniotic fluid. RHEO™ is carefully cryopreserved using our proprietary CryoGen™ process, to ensure that it retains the structural and bioactive properties of amniotic tissue. Its anti-inflammatory, anti-microbial, and regenerative properties make RHEO™ an ideal option for patients who are looking for minimally invasive treatment options that promote healing and reduce pain and inflammation.

Human amniotic allografts have a long history in regenerative medicine1, and RHEO™ leverages the healing power of amniotic tissue in a new way. Unlike traditional amniotic allografts, RHEO™ is a flowable tissue matrix that delivers bioactive cytokines and growth factors to promote non-fibrotic healing. Since it’s injectable, RHEO™ is a minimally invasive treatment option that can reduce pain and promote healing with little downtime, and it is uniquely suited to address musculoskeletal concerns that conventional allografts can’t reach.

RHEO™ is available in 0.5, 1.0 and 2.0 mL sizes.

Immunosuppressive Properties of Amniotic Membrane

The amniotic membrane is the immunologically privileged inner layer of the placenta. Amniotic cells are non-immunogenic, multipotent stem cells that exert their actions through trophic mechanisms, including secretion of paracrine-acting cytokines and growth factors that have immunoregulatory properties. The amniotic membrane also has an organized extracellular matrix (ECM) made of collagen, elastin, fibronectin and proteoglycans. The ECM serves as an avascular stromal scaffold for tissue development and repair, but it is also an important regulator of cytokine and growth factor signaling.

Amniotic epithelial and mesenchymal stromal stem cells exert multiple immunosuppressive activities, including inhibiting activation and proliferation of CD4+ and CD8+ T cells and B cells, and promoting activation of anti-inflammatory M2 macrophages and regulatory T cells (Tregs)2. More recently, they have been shown to inhibit the release of pro-inflammatory IFN-γ from cytotoxic natural killer (NK) cells and block differentiation of monocytes to dendritic cells3-4. Together, these immunosuppressive effects block microglial migration and immune cell recruitment, attenuate oxidative stress, and enhance tissue regeneration.

Benefits of Amniotic Fluid

While the amniotic membrane has received the most attention as a regenerative therapy, we’re learning that amniotic fluid is equally as beneficial. Hyaluronic acid (HA) is a well-known ECM component, but it’s also found in high concentrations in amniotic fluid, where it increases the fluid viscosity and supports fetal movement. HA-mediated signaling is thought to be the reason why fetal wounds lack fibrous scarring, and when HA is applied to fresh wounds in adults, they heal with less scarring5. In addition, amniotic fluid contains numerous growth factors and proteins that have been shown to improve bone healing, regenerate nervous tissue, and prevent fibrogenesis6-9.

Flowable amniotic tissue allografts have recently been evaluated as a treatment option for several challenging conditions, with impressive results. For example, intra-articular injection of cryopreserved human amniotic suspension allografts was shown to reduce pain and improve joint function in people with symptomatic knee osteoarthritis10. In another study, injected amniotic allografts improved symptoms of plantar fasciitis11. A third study showed that local injection of amniotic tissue promoted peripheral nerve regeneration and ameliorated peripheral neuropathy12.

Anti-inflammatory properties of Amniotic Membrane

Tissue transplantation can often provoke an inflammatory response known as a foreign body reaction. While sometimes, this inflammation can be beneficial and trigger the healing of an injury, it can also lead to implant failure and rejection. Foreign body reactions evoke stimulation of giant cells and macrophages that produce cytokines and attract fibroblasts, leading to fibrosis. The fibroblasts are activated by the transforming growth factor TGF-β1. The amniotic membrane down-regulates TGF-β1 and its receptor expression by fibroblasts and, in doing so, reduces the risk of fibrosis. This means that an amniotic membrane scaffold can modulate the healing of a wound by promoting natural tissue reconstruction rather than promoting the formation of scar tissue.13

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References
1. Silini, A.R., et al., The Long Path of Human Placenta, and Its Derivatives, in Regenerative Medicine. Frontiers in bioengineering and biotechnology, 2015. 3: p. 162-162.
2. Li, H., et al., Immunosuppressive factors secreted by human amniotic epithelial cells. Invest Ophthalmol Vis Sci, 2005. 46(3): p. 900-7.
3. Chatterjee, D., et al., Role of gamma-secretase in human umbilical-cord derived mesenchymal stem cell mediated suppression of NK cell cytotoxicity. Cell Commun Signal, 2014. 12: p. 63.
4. Banas, R., et al., Amnion-derived multipotent progenitor cells inhibit blood monocyte differentiation into mature dendritic cells. Cell Transplant, 2014. 23(9): p. 1111-25.
5. Nyman, E., et al., Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid: in vitro studies of re-epithelialisation in human skin wounds. J Plast Surg Hand Surg, 2013. 47(2): p. 89-92.
6. Karacal, N., et al., Effect of human amniotic fluid on bone healing. J Surg Res, 2005. 129(2): p. 283-7.
7. Ozgenel, G.Y. and G. Filiz, Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg, 2003. 98(2): p. 371-7.
8. Bolat, E., et al., Investigation of efficacy of mitomycin-C, sodium hyaluronate and human amniotic fluid in preventing epidural fibrosis and adhesion using a rat laminectomy model. Asian Spine J, 2013. 7(4): p. 253-9.
9. Sessarego, N., et al., Multipotent mesenchymal stromal cells from amniotic fluid: solid perspectives for clinical application. Haematologica, 2008. 93(3): p. 339-46.
10. Vines, J.B., et al., Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg, 2016. 29(6): p. 443-50.
11. Hanselman, A.E., J.E. Tidwell, and R.D. Santrock, Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int, 2015. 36(2): p. 151-8.
12. Li, Y., et al., Amniotic mesenchymal stem cells display neurovascular tropism and aid in the recovery of injured peripheral nerves. J Cell Mol Med, 2014. 18(6): p. 1028-34.
13. European Cells and Materials Vol. 15 2008 (pages 88-99) DOI: 10.22203/eCM.v015a07