Plymouth, MA-based Harvest Technologies is following up favorable pilot study results with a larger trial of its of autologous bone marrow aspirate concentrate product for treatment in patients with critical limb ischemia (CLI).
Investigators, mostly vascular surgeons, for the national randomized controlled double-blinded trial have begun enrollment of a planned 210 patients with CLI and tissue loss (Rutherford class 5) at up to 40 centers and will evaluate amputation-free survival, change in Rutherford class, and pain levels at six months.
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