The first in-human, single center, open label, prospective, randomized study enrolled 10 patients with non-revascularizable moderate or severe lower extremity peripheral artery disease (PAD). The aim of the pilot study was to assess safety and preliminary efficacy of using low frequency ultrasound (LoFU) to deliver adipose derived stem cells (ADSCs) to ischemic tissues to improve microcirculation in patients facing limb amputation. The LoFU therapy was delivered with SonaCare’s SonoSource LoFU device platform.
Wilson Wong, MD, from Arkansas Heart Hospital and PI of the study said, “Efficacy of stem cell therapy has been limited by problems of ‘homing’ and retention of the given stem cells to stay at intended location long enough to be effective. This first in human pilot study shows exciting and promising result that LoFU may be the answer, and warrant larger scale, phase III clinical trial.”
“The next step will be a Phase III study,” said Naren Sanghvi, MD, PhD, SonaCare Medical’s Chief Scientific Officer. “It is also a natural next step for SonaCare to use our SonoSource platform to expand the applications of focused ultrasound that offer noninvasive solutions to difficult medical problems.”
Although it was a small study and additional work is needed, the group found positive initial results from pretreating the affected area with LoFU prior to ADSC injection. The application was safe and could be promising method for improving function in lower extremities with damaged blood vessels.
See First in Human Phase I/Phase II Safety and Preliminary Efficacy Study Using Low Frequency Ultrasound in Addition to Adipose Derived Stem Cells in Patients with Moderate to Severe Lower Extremity Peripheral Arterial Disease >