SANUWAVE Health, Inc. (OTCBB: SNWV), today announced the
publication of peer-reviewed, preclinical research that demonstrates the
ability of the Company's Extracorporeal Shock Wave Technology (ESWT) to
stimulate proliferation of periosteal adult stem cells (cambium cells)
within the body and subsequently form bone. In addition, the combination
of ESWT-proliferated adult stem cells and a bioactive scaffold
regenerated more bone than a bioactive scaffold alone.
The publication, titled "The Use of Extracorporeal Shock Wave-Stimulated
Periosteal Cells for Orthotopic Bone Regeneration," appeared in the
online edition of Tissue Engineering, Part A as an ePublication
ahead of print. The abstract of the publication can be viewed online at: http://online.liebertpub.com/doi/abs/10.1089/ten.TEA.2011.0573.
Led by Myron Spector, M.D., a professor and researcher at Harvard-MIT
Division of Health Sciences and Technology, the authors stated, "This
study investigated a novel approach for treatment of bone loss, which
has potential for many clinical situations where bone apposition is
required (e.g., vertical ridge augmentation, regrowing bone following
tumor resection, and regenerating bone lost at sites of osteolysis or
bone degeneration)."
"The cambium cells of the periosteum (outer membrane covering bone)
currently have limited suitability for clinical applications in their
native state due to their low cell number (only 2 to 5 cells thick).
However, ESWT has been shown to cause a rapid increase in periosteal
cambium cell numbers and subsequent periosteal osteogenesis (bone
formation). The advantages of adding a scaffold as we did in this study
are threefold: the scaffold contours the new bone, it helps maintain
bone at the implant site, and it creates a space to allow the periosteal
cells to further proliferate and fill the scaffold."
The authors concluded, "The ESWT-stimulated samples of tibial bone
outperformed the control group in all key outcome variables, and the
study results therefore demonstrated the efficacy of ESWT-stimulated
periosteum for bone generation. These results successfully demonstrated
the efficacy of periosteum stimulated by ESWT technology for bone
generation."
In the first phase of this research, the authors successfully
demonstrated that ESWT increased the thickness of the cambium layer
surrounding bone and the number of cambium cells within that layer. This
proliferation of adult stem cells is an important part of many tissue
engineering strategies. Then, in a novel second phase, the authors
combined the ESWT-proliferated adult stem cells with a porous calcium
phosphate scaffold that is commonly utilized in clinical applications to
stimulate bone regeneration. A comparator control group received the
scaffold alone with no prior ESWT treatment. The results were
statistically significant and favored the ESWT group. In fact, at two
weeks post-surgery, there was a significant increase in all key outcome
variables for bone growth favoring the group that received ESWT prior to
being combined with a scaffold compared with the group that received
only the scaffold.