Regenerative Medicine

Regenerative Medicine

Regenerative medicine is expanding rapidly with more resources being directed to investigate the break through possibilities within the field.  PRP treatments, Bone Marrow Concentrate (BMC) stem cell therapies, Umbilical Cord Blood(UCB) are the most common origins of growth factors and cytokines.  Safe and effective therapies are the basis of stem cells that are currently FDA cleared but many companies are claiming cell counts without actual verification.

PRP Kits | Platelet Rich Plasma Kits

PRP Treatment Cost

Platelet Rich Plasma treatment costs vary per physician, region, and the PRP kit supplier utilized, but on average PRP procedures are between $700-$1,200.00 per treatment site.  The PRP centrifuge utilized is a crucial component to PRP treatments and vary greatly on their operation, cost and regulation.  The Arthrex Angel and ISTO Biologics Magellan are two of the leading centrifuge technologies that work as concentrators.  Magellan system by ISTO Biologics utilizes a laser to insure cell concentrations.  Emcyte is a newer company with several distributors throughout the United States.  Emcyte’s spin cycle is 5 minutes with visual verification of concentration by the physician or staff member.

Biomet also utilizes a visual verification of the spin cycle concentrations as well.  Their BioQ PRP kit sells to the physician between $150-$300.00 per kit.

Stem Cell Therapy

Nearly every medical specialty is researching & experiencing benefits with stem cell therapy and stem cell companies are expanding and improving their stem cell regenerative medicine products.  Oncology, Neuroscience, Orthopedic Centers, Pain Management Centers, Plastic Surgery and Wellness Centers are investing in quality stem cell therapy products.

Stem Cell Companies

The FDA released new guidelines to set guidance for science based regenerative biologic practices.  Here are a few questions to ask a regenerative medicine supplier.

• Is your product FDA 351 or 361 designated?  A cGTP 361 designated company and product cannot make a live cell function claim from a 361 derived tissue.
• What is your medical device classification and what sector of the FDA regulates it? There are two FDA sectors that regenerative companies operate under.  CBER is the Center of Biologic Evaluations & Research. The CBER provides expertise in blood, blood products and cellular therapies.  This clearance route assumes that the centrifuge output product has a biologic intended purpose, and legally must be called platelet rich plasma(PRP) regardless if from whole blood or bone marrow.  identifying a product as PRP does not mean that the biologic only contains concentrated platelets.  Centrifuge machines that obtain clearance in the CBER sector start with a “BK” and ascertains an in vivo indication for use. The CBER classification enables a centrifuge manufacturer to claim that use of their product is “on-indication” for application to an orthopedic site.  Arthrex Angel and ISTO Biologics Magellan system are classified under CBER.

The second FDA sector in the regenerative companies work under is the CDRH which is the Center for Devices & Radiological Health.  The CDRH avenue for a centrifuge product has a in vitro diagnostic purpose and can be called a cellular concentrate, but carries NO clinical application indication.  This means that the output product has no planned return to the patient.  Meaning there are no orthopedic applications for these devices “on-indication”.  Centrifuge model numbers under CDRH start with the letter “K”.  CDRH designated centrifuges do not include in vivo indication for use. Emcyte, Apex Biologics, and Terumo BCT’s Harvest system are designated CDRH.

Stem cell therapy procedures include:

• Stem cell therapy for knees
• Stem cell therapy for arthritis
• Stem cell therapy for spinal injuries
• Stem cell therapy for hips
• Stem cell therapy for ankles