Harvest Technologies, FDA Approval of IDE Trial to treat Patients with CLI
The FDA has approved Harvest Technologies’ (HT) sponsored 210 patient IDE clinical trial to be conducted at 25 sites in the US using the company’s proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI).
- The pivotal study will enroll 210 patients with data analysis after the last subject has completed 6 months of follow-up. HT anticipates that enrollment should begin early in Q2/11.
HT is working with Medical Centers across the US helping document what may be a significant treatment option for this extremely sick, no treatment option, patient population. The results generated from the 48 patients FDA safety and pilot study and the results of the BMAC studies in EU and Asia, which treated over 300 end-stage CLI patients, have all been extremely encouraging.
The Bottom Line: The Harvest pilot trial utilizes the BMAC system, which processes the cells in 15 minutes in the operating room. A unique feature of both the upcoming pivotal trial and the preceding pilot trial was that it compared the relative effectiveness of the BMAC to a control injection of a placebo and detailed the safety profile of the device and the technique. The Harvest BMAC System is a simple to use 15 minute point-of-care process that has been used in the treatment of approximately 50,000 patients to date. The System concentrates the cellular composition of the patient’s bone marrow, which contains the patient’s own stem cells. The BMAC System’s point-of-care approach, ease of use and its ability to deliver a cellular composition at an affordable price will be a major key in establishing this technique as a standard of care after the Company has received its FDA approval. Autologous cell therapy is a treatment option for CLI, such as used by Aastrom Biosciences (ASTM) however, previously studies did NOT use a rapid, point of care method for processing the cells.