We Provide Physicians with the Technology and Quality System to Treat Patients

Using Autologous Biological Preparations

The goal at Greyledge is to provide physicians with the technology and quality system to treat patients with a variety of autologous biological preparations in their practice of regenerative medicine. The advantage of Greyledge Technologies’ platform technology is its turn-key approach so that a physician can effectively offer autologous biological preparations customized to their patients’ needs. The preparations themselves are produced by a sterile process in a closed tissue culture hood, and are characterized in a 27-parameter analysis with a hemoanalyzer. The standard processing time is approximately 25 minutes, with the analysis available within that processing window, allowing physician review prior to treating the patient. The availability of a 27-parameter sample analysis allows the physician a chance to modify the biologic preparation’s composition based on their clinical practice. The procedures used for processing and analysis are fully documented as a part of a comprehensive quality system that is integral to the service Greyledge provides to its clinical partners.

The use of a patient’s own biologic preparation complements the natural healing process present in patients, which has been reported in the clinical literature to result in pain mitigation, tissue regeneration and/or repair. However, the natural healing process is complex and varies among patients, since it depends on a variety of active components working together. There are three major types of active components as follows:

Cells
Signals
Scaffolds

As described in the literature (e.g., Murphy, et al. 2013), cells participating in the natural healing process consist of:

Mesenchymal Stem Cells (MSCs) and Hematopoietic Stem Cells (HSCs), originating from bone marrow and blood.

Multipotent Cells, from other sources, including peripheral blood.

Native tissue cells, stimulated to grow/proliferate in response to growth factor signals.

Refer to a variety of human growth factors and other proteins, which primarily are present in plasma and platelets, but also can be produced by progenitor cells like MSCs.

Refer to a proteinaceous matrix that supports tissue growth within the body. In the process described here, the primary protein typically is blood-based fibrinogen, which upon activation by the clotting cascade can create a multi-protein component scaffold.

One or more of the trio of active components present in the patient’s autologous biologic preparations can be applied to injured or pathologic tissue to support repair or regeneration. Methods of implantation include percutaneous (injection) or intra-operative (surgical) application.

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HOW DOES GREYLEDGE PROVIDE AUTOLOGOUS BIOLOGIC PREPARATIONS?

Greyledge provides a physician with an opportunity to customize the autologous biologic preparation prior to treatment (see lower diamond and red font). For example, a physician might want to have a higher platelet count in the patient’s BMCC than is present in the bone marrow aspirate. Whole blood can be drawn and processed to produce a low-RBC PRP, which can be mixed with the existing BMCC, thereby boosting the BMCC platelet content.

Schematic Chart

Commitment To Quality

An integral part of the goal of providing autologous biologic preparations for treating patients is the Greyledge commitment to quality. As a part of its service, Greyledge provides a fully documented quality system, which establishes a framework for producing biologic preparations that meet physician-established targets, in support of a physician’s practice of medicine.

Accurate, multi-staged hemoanalysis of every tissue sample and biologic preparation provides a physician with information about the sample before the patient receives it.  Appropriate volume and concentration adjustment formulas address the expected patient-to-patient variability in platelets and cell counts. Through concentration or dilution of final preparations, Greyledge ensures that the patient’s biologic meets the physician’s requirements.

All tissue is handled and processed with strict aseptic technique, as reflected in the Quality Manual. Qualified laboratory technicians who have successfully completed internal training, and are phlebotomy-certified, handle and process the tissue. Tissue samples and preparations are processed in the Greyledge laboratory, which is in close proximity to the treatment suite. Sample handling, accurate patient tissue identification, product sterility and characterization of the final autologous biologic preparation are controlled with strict and detailed protocols to ensure accuracy and safety throughout the process.

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Read about how quantitative, autologous preparations have been reported for treating a wide variety of pathologies.