Biologics – Where’s the Damn Evidence?

What Are So-called “Stem Cells” Supposed to Do?

If these clinics are to be believed (and the FDA’s warning letter from August 2017 would suggest the majority are full of BS), the “stem cells” they inject in patients will:

• Relieve pain and improve function in arthritic large joints
• Relieve soft tissue inflammation
• Grow bone
• Treat spinal cord injuries
• Treat immunological conditions
• Ameliorate cardiac disease and pulmonary disorders
• Treat ophthalmologic disease and injury
• Relieve urological disorders
• Treat Alzheimer’s
• Treat essential tremor diseases
• Address necrotic bone
• Provide a facelift
• Augment breasts
• Enhance sex

To be blunt, marketing has gotten way ahead of the science.

Rules of the Road for Mixed Cell Therapies

The American Academy of Orthopaedic Surgeons (AAOS) convened a symposium on the subject of living cell implants and issued recommendations covering nomenclature, standards for measuring and reporting the composition of these therapies and their clinical outcomes and registries and clinical trial networks to accelerate rigorous assessment and optimization of regenerative therapies for musculoskeletal diseases.

They urged physicians to:

• Refer to minimally manipulated cell products and tissue derived culture-expanded cells as “cell therapy” not ‘stem cell’ therapy.
• Inform patients that these therapies are largely untested and uncharacterized.

They urged suppliers to conduct rigorous studies of their non-BMP biologics which:

• Use AAOS symposium checklists as a guide for study design and reporting.
• Disclose the detailed composition of PRP and cell-based therapies.
• Identify the biologic activity target (e.g., cell proliferation, anti-inflammatory, antifibrotic effect) for their non-BMP biologic.

The Unique Case of Medtronic’s Infuse™

The paucity of clinical evidence for today’s wave of living cell implants and other biologics stands in sharp contrast to the enormous body of clinical evidence behind BMP -- specifically Medtronic’s Infuse™.

Since it was approved by the FDA in 2002, the spine research community jumped on this landmark biologic and generated hundreds of studies and wrote thousands of clinical papers, from level I on down to case studies, some with Medtronic financial support, but most not, and submitted them to dozens of peer-reviewed publications.

This body of evidence about BMP is significant and has, we think, served the physician community well. It is quite likely true that Infuse® is THE single most studied biologic in the history of spine and orthopedics.

Brett Knappe, Ph.D., VP of Biologics at Medtronic, told OTW: “The safe and effective use of Infuse is backed by years of scientific development, clinical trials and two decades on the market with more than 2,000,000 patients treated.”

Medtronic is still investing in BMP clinical trials having recently announced one for TLIF [transforaminal lumbar interbody fusion] indications and another for PLF [posterior lumbar fusion].

Medtronic’s new campaign—"Think Twice Fuse Once"—which was front and center at NASS, parallels AAOS’ new guidelines and urges physicians to ensure that biologic use is informed by the needs of the patient, the site, the procedure, and is based on strong data and evidence.