This area includes a wide range of therapies and possible treatments. Many of our functional and integrative approaches are regenerative and rejuvenative in nature, so you have many options in regenerative medicine. One of the groups of therapies gaining the most traction is in the area of biologic allograft therapy.

Biologic Allograft Therapy

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.

Biologic Allografts also contain factors that can affect immune response. In research studies, these immune factors have been shown to lower inflammation.

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 growing number of companies which distribute these products to physicians for use in regenerative medicine therapies. Many products are delivered cryopreserved on dry ice and are strictly compliant with FDA standards under Current Good Manufacturing Practice (cGMP) regulations. The few FDA approved and FDA RMAT products available do not currently require cryopreservation and are also strictly compliant with FDA standards under Current Good Manufacturing Practice (cGMP) regulations.

Tissue donation is guided by the American Association of Tissue Banks (AATB) for quality, safety and ethics. The products are sourced from the umbilical cord and/or amniotic fluid of healthy donor volunteers painlessly and non-invasively. Each donor is carefully screened for pathogens in order to assure the product is safe.

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.

Potential/theoretical risks (i.e. risks observed in animal studies) include tumor formation, unwanted immune responses, worsening of your condition, new conditions as a result of the therapy, cells differentiating into unwanted tissue or causing existing cells to change their behavior.

The risk of donor-to-recipient transmission of bacterial, viral, fungal or prion pathogens may lead to life-threatening and even fatal reactions. The immune suppressing nature of MSC may allow a dormant infection already in the body to become active, e.g. a flare of herpes virus, etc.

MSC have been used extensively in clinics for decades. The clinical experience with these therapies indicates that administration of MSC did not reveal major health concerns, and is generally not accompanied by tumor formation. However, limitations of the safety database (i.e. number of patients treated) and lack of long-term follow-up required to study potentially rare adverse events should be taken into account when evaluating the tumorigenic potential of MSC.

The vast majority of small-sized clinical trials conducted with MSC in regenerative medicine applications have not reported major health concerns, suggesting that MSC therapies may be relatively safe.

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