An Institutional Review Board (IRB) is a worldwide recognized process charged with protecting the safety and dignity of those receiving experimental treatment (Clinical Research.IO).
The IRB and registry process follow rigorous standards to protect patients’ safety and privacy while gathering clinical information so that further studies, such as an IND, may ultimately lead to a FDA approved process that would be insurance reimbursable.
In each of these processes, your name and identifying information is removed from all documents and then uploaded into a database. The purpose of the database is to provide an organized location to house the results of stem cell treatments and report upon their findings.
In the interest of safety and privacy, stem cell treatments will only be provided to patients who participate in one of these processes.
This process affords you the opportunity to legally enjoy the benefits of what is presently an experimental therapy instead of having to travel to a country where such treatments are not regulated – and potentially unsafe.
For instance, there is one US provider that operates an offshore clinic where bone marrow derived stem cells are cell cultured to increase their number and then injected in the patient at a later date. The process of cell culturing (which we don’t do) is a process that violates the FDA minimal manipulation clause of the same day surgery exclusion. Fat harvesting and transfer to the same patient, i.e. fat transfer to the breast, face, buttock or other body part, does not require significant manipulation of the fat and is being utilized in a homologous fashion – meaning that fat is transferred into an area where fat normally resides and its function is the same. Non-homologous use would be using a product indicated for a specific area and applying it to another area where those cells would not normally reside. An example would be utilizing a cord blood product that is indicated for reestablishing red blood cells and applying it to a knee joint for arthritis treatment.
There are 3 options for treatment. The first option takes a sample of fat and then and then processes it to make the fat injection much smaller (Nanofat). Nanofat is then mixed with high density PRP and injected into the joint. The second option combines Nanofat, high density PRP and stem cell solution (cellular stromal vascular fraction- cSVF) and is likewise injected into a joint. The third option delivers the stem cell solution-cSVF via an intravenous infusion.
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1 Regenerative therapy repairs to body tissues are permanent as compared to joint replacements, which must be re-replaced in the future. Multiple stem cell treatments may be required for severely damaged joints.