Type of Therapies

Regenerative Medicine Therapies

Anti-inflammatory

NSAIDS

Steroids

Synthetic Hyaluronic Acid

Platelet Rich Plasma (PRP) *

Amniotic Fluid Liquid Suspension *

Amniotic Fluid + ECM Liquid Suspension *

Wharton’s Jelly Liquid Suspension *

Cellular Products

Lipoaspirate Concentrate

Bone Marrow Aspirate Concentrate

Umbilical Cord Blood

Umbilical Cord MSC

 

 

 

 

Current Autologous Therapies

Platelet-Rich Plasma (PRP):

Platelet-rich plasma therapy is a common therapy and used extensively in specialties of dermatology, orthopedics and dentistry.

PRP contains several different growth factors and other cytokines that can stimulate healing of bone and soft tissue.

As of 2016, no large-scale randomized controlled trials have confirmed the effectiveness of PRP in preclinical trials to treat musculoskeletal injuries (including tendinitis, nerve injuries), help in bone grafting or androgenic hair loss.

There are no standard protocol exists but main principles essentially involve concentrating platelet in a concentration of 3– 5 times the physiological value and then injecting this concentrated plasma in the tissue where healing or effect is desired.

Adipose Derived Adult MSCs:

Adult stromal cells intended for regenerative therapy can be isolated from the patient's bone marrow or from adipose tissue.

Mesenchymal stem cells may differentiate into the cells that make up bone, cartilage, tendons, and ligaments, as well as muscle, neural and other progenitor tissues, they have been the main type of stem cells studied in the treatment of diseases affecting these tissues.

The number of stem cells transplanted into damaged tissue may alter efficacy of treatment. It takes approximately 60cc’s of adipose to obtain 1cc with over a million cells.

Bone Marrow Aspirate Concentrate (BMAc):

Marrow stromal cells are used every day in regenerative orthopedics. The knee microfracture surgery technique popularized by Steadman relies on the release of these cells into a cartilage lesion to initiate fibrocartilage repair in osteochondral defects. For this application, bed side centrifugation is commonly used.

Again, these techniques produce a very dilute MSC population, Despite this low number of MSC’s, isolated bone marrow nucleated cells implanted into degenerated human peripheral joints have shown some promise for joint repair.Once these MSCs are ready for re-implanation, they are usually transferred with growth factors to allow for continued cell growth and engraftment to the damaged tissue.

At some point, a signal is introduced (either in culture or after transplant to the damaged tissue) for the cells to differentiate into the end tissue (in this discussion, cartilage).

Autologous Pros and Cons

PROS

Known source of MSCs

Reduced risk of rejection or inflammation

Reduced potential for bacteria or virus transmission

 

 

 

CONS

Requires a surgical procedure

Additional capital, disposable, surgical and time costs

Potential morbidity complications

Low concentrations

Lipoaspirate 4,500 – 450,000 MSCs per CC

BMAC – 30 – 300 MSCs per CC

Homologous Cell and Tissue Products (HCT/Ps):

In 1980’s the FDA asserted authority of human tissue. In 1993 the FDA created two pathways for regulating homologous tissue and cell products by statue with Part 1270 of Title 21, CFR (Codes of Federal Regulations)

Section 361: Minimally manipulated tissues and cells, intended for homologous use only, and not combined with another article, with some exceptions..

*Regulated by American Association of Tissue Banks (AATB)

Section 351: Biological products derived from living material– human, animal or microorganism – applicable to the prevention, treatment or cure of a disease. These products meet the definition of a Therapeutic Biologic Application (BLA)

*Regulated by the FDA Center for Drug Evaluation and Research (CDER)

Homologous Pros and Cons

PROS

High concentrations of MSCs

Umbilical Cord 1 million per CC

Epigenetically young cells

Quick, easy and reproducible

No capital, surgical or time costs

No known complications

 

CONS

Potential for bacteria or virus transmission

Less than blood transfusion

Logistics and handling considerations

LProducts must be shipped and stored -200º