This area includes a wide range of therapies and possible treatments. Many of our functional and integrative approaches are anti aging and rejuvenative in nature, so you have many options in this arena of medicine. One of the groups of therapies gaining the most interest is in the area of biologic allograft therapy.
Biologic Allograft Therapy
**Due to newly implemented FDA guidelines many of these products are no longer available, please contact us for more information**
An allograft is a biologic scaffold, also know as extracellular matrix (ECM) usually composed of laminin, fibrinectin, elastin, and other molecules or cells. An allograft can also be tissue that is transplanted. (Allograft – UCSD CME – University of California San Diego)
Allografts may contain “stem” cells or MSCs (medicinal signaling cells), which are undifferentiated cells that have the ability to self-replicate and possibly change into specific cell types in the body. Exosomes and other signalling factors are also part of biologic allografts. These allografts can be injected directly into or near an area of injury. Cells have a “homing” ability to go to areas of injury due to signals released by injured cells. Once at the site of injury or inflammation they assist in repair of the injury or disease by releasing growth factors and immune modulators that assist in the body’s natural repair process.
There are thousands of peer-reviewed publications showing successful use of biologic allograft therapy. However, most biologic allograft products are not FDA approved. The few that are FDA approved are used primarily for wound and orthopedic indications. There are many ways in which human cells can be used in research and the clinic and more therapies are becoming possible as the research and development expands in this field. (https://stemcells.nih.gov/info/basics/7.htm)
Biologic Allograft Sources
Biologic allograft material is available from a number of companies which distribute these products to physicians for use in anti aging medicine therapies. Products are strictly compliant with FDA standards under Current Good Manufacturing Practice (cGMP) regulations. FDA Regulations concerning these products are always changing affecting the availability of products and therapies.
Important Notes about “Stem” Cell Treatments
Because cells that are specific to certain tissues cannot make cells found in other tissues without careful manipulation in the lab, it is uncertain if so called “stem” cell treatment will work for diseases affecting different tissues and organs within the body.
The list of diseases for which these treatments have FDA approval is short. The best-defined and most extensively used stem cell treatment is bone marrow transplantation for certain blood and immune system disorders or to rebuild the blood system after certain cancer treatments. Some bone, skin and eye injuries and diseases can be treated by grafting or implanting tissues, and the healing process appears to rely on signaling cells within this implanted tissue. These procedures are widely accepted as safe and effective by the medical community. All other applications of “stem” cells are yet to be proven in clinical trials and should be considered experimental.
FDA guidelines regarding these and similar products are constantly changing and affecting the availability of product and subsequent treatments. Please contact us if you are considering therapy of this nature, as we stay on top of the current regulations, trends and research.
For more information on this topic please contact us.
Resources
Risk Factors in the Development of Stem Cell Therapy
FDA Warns about Stem Cell Therapies
Top take-homes from new FDA NEJM stem cell piece including surprises