CLI stem cell research study (Un of Davis) involves using a patient’s own stem cells to increase blood circulation to the lower leg with the hope of preventing amputation due to severe arterial disease or diabetes.
- The study involves a 1 to 2 hour surgical procedure during which bone marrow is harvested from the pelvis and spun in a centrifuge to separate mononuclear cells. These cells consist of white blood cells and mononuclear stem cells containing concentrations of endothelial progenitor cells. The separated stem cells are injected at multiple points into the muscle of the leg at risk for amputation. Patients remain in the hospital overnight and return to the UC Davis Vascular Center in Sacramento for a series of 5 follow-up visits over the course of a year.
The trials sponsor, Biomet Biologics (NYSE:BB) manufactures MarrowStimª used to extract blood cells from bone marrow along with the high-speed, table-top centrifuge that separates and concentrates the mononuclear cells, making delivery easy to treatment targets. BB recently completed P I safety study and the results were used to refine the technology and launch this new national FDA approved trial.
Biomet (now private), its subsidiaries design, manufacture, and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy. BB’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and soft-goods and bracing products.
The Bottom Line: This is an early phase trial, but the desktop application resounds! ASTM also uses patients’ bone marrow to manufacture its vascular repair cells product to generate re-growth of blood vessels in patients with CLI. ASTM’s process (formerly the TRC) is based on a mixed cell population providing all the necessary cells to promote new tissue growth but, samples need to be harvested and sent to be reconstituted. A quite different therapy, PSTI’s approach is using immune-privileged cells sourced from the maternal side of the placenta offering an allogeneic “off the shelf”, pharmaceutical like product with autologous like properties. Another private company is Harvest Technologies who also has been focusing its commercialization efforts to support clinical research for the treatment of CLI. Harvest® Technologies’ BMAC™ (Bone Marrow Aspirate Concentrate) System device is currently being used in the EU to treat vascular, orthopedic and cardiovascular diseases. The use of a clinically effective quantity of cellular compositions from a small aspirate of autologous bone marrow includes a large quantity of adult stem cells, derived from a patient at the point-of-care in just 15 minutes. They each have their issues! Could one key to this therapy be the desk-top application eliminating patient’s lengthy wait and depending on trial results - to partnering as the competitive metric? Look for the major device companies to move or partner in the biologics universe!