Biologics

This category refers to the Holy Grail of spine medicine. Scientific studies are ongoing for the development of medical compounds that actually “heal” disc degeneration/injury. While the problem remains unsolved, science is creeping closer everyday.

Fibrin Sealant

At the 17th Annual Scientific Meeting of the International Spine Intervention Society (ISIS) an abstract entitled “Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up” was presented by authors Way Yin, MD et al. The purpose of this study was to assess the safety and preliminary efficacy of BIOSTAT BIOLOGX® Fibrin Sealant in human adults with chronic symptomatic lumbar internal disc disruption (IDD). The sealant occludes the anular fissures and lays down a tissue repair matrix. Essentially, it functions as a physical barrier between inflammatory substances in the disc and nerves within the fissures, and serves as a scaffold for tissue repair.

Fibrin Sealant

Figure X. Provocative Discography at L3-4, L4-5, L5-S1

The original study included 15 adults with chronic axial low back pain (CLBP). These patients had “failed” conservative therapy and were deemed appropriate for this study after provocation. Initial data suggested intradiscal fibrin sealant injection might improve pain and function in selected patients with IDDS.

In 2014, results from a multi-centre randomized controlled trial (RCT) demonstrated the efficacy of this fibrin sealant compared with placebo. Clinically significant improvements in pain and function were demonstrated at 24 months follow up. Tremendous excitement was generated from this study.

Unfortunately, the Phase III trial for fibrin sealant did not meet expectations.  This larger multi-centre RCT was stopped after 6 months due to the fact early results were disappointing. Fibrin sealant did not demonstrate a satisfactory level of efficacy versus placebo and has not become the standard of care.

 

Stem Cell Therapy

Stem cell use has become the object of media frenzy, stoking, both public and research interests, due to the potential for tissue regeneration. Autologous (from our own body) stem cell use requires the harvest of large numbers of cells with subsequent use of special laboratory techniques for clonal expansion (multiply) to a differentiated (specialized) nuclear chondrocyte cells (the cells that regenerate our disc material). Next, these specialized cells need to be careful placed into your own disc in a way that is safe and effective.

A controlled clinical trial of this technique, using stem cells is in process. The use of mesenchymal stem cells (MSC) has been studied in animals with some early investigations of MSC implantation in humans. Large quantities of MSC can be obtained from peripheral blood, bone marrow, or fatty tissues using commercially available liposuction techniques. In all cases, the retrieved biologic material can be processed quickly in the operating room to yield a cellular product that can be injected intradiscally. It appears that some clinics around the world may be offering this modality, although human clinical trial data are unavailable to evaluate this practice.

The media has driven a lot of attention toward the use of stem cells to treat many medical conditions. Back pain is no exception. We are optimistic stem cell therapy will be proven successful. However, we should wait for the scientific data before making conclusions.