Harvest Technologies reports encouraging interim results from ischemia trial

Harvest Technologies, a developer of new technologies for accelerating healing, has announced that the interim study report was completed for the first 30 patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to advanced thromboangitis obliterans, commonly referred to as Buerger’s disease.

The trial is being conducted at Sri Ramachandra University in Chennai, India and is designed to evaluate the therapeutic effect of a composition of nucleated bone marrow cells prepared using the Harvest SmartPReP system.

Patients enrolled in the trial were treated with a composition of concentrated bone marrow nucleated cells, termed BMAC. A total of 240ml of marrow aspirate was processed using the point of care SmartPReP System to yield 40ml of treating volume.

According to the company, the interim evaluation of these patients conducted at 12 weeks showed convincing evidence that the treatment had significant clinical effect. The most important finding was that 87.5% of patients were able to save their legs. Other major endpoints also showed significance improvement.

Quality of life assessment (Rand-36 questionnaire) and individual perception of pain showed statistically significant improvement (p=0.0009 and 0.0001 respectively). There was 100% reduction in the use of pain medications. Limb perfusion, as measured by TcPO2 and ABI also showed statistically significant improvement (p=0.0001 and 0.0003 respectively). 33% of the patients had serious ulcers and 90% of these showed 90% or better wound closure in 26 weeks, the company said.

Harvest and its agent in India are hopeful that this data along with data generated in Europe will aid in obtaining the necessary clearances for the marketing the Harvest BMAC System for the treatment of critical limb ischemia (CLI) in India before the end of 2009.