Cook Regentec has recruited the first patient in a global clinical trial to assess the HemaTrate blood filtration system for treating patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD).

For the treatment of CLI, the HemaTrate system generates an autologous and peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular injection into the ischemic limb.

The study’s principal investigator professor Bijan Modarai said: “Critical limb ischemia is the final stage of peripheral arterial disease and is associated with major morbidity and mortality despite current medical and surgical treatment.”

The clinical trial is set to recruit up to 350 patients

The randomised, controlled and multicentre HemaTrate CLI (HT-CLI) study will recruit around 350 patients.

Cook will randomise subjects with Rutherford class 4 or 5 CLI to secure a series of three intramuscular injection treatments of TNCs or saline, six weeks apart.

According to the company, the primary endpoint is clinical benefit through 12-month follow-up, defined as freedom from reintervention, major amputation or death.

All patients will be provided TNC treatment for both study and non-study limbs, following the 12-month study period. The patients will be followed for two years.

Cook Regentec business leader Brad Shirley said: “Patients with PAD-associated CLI who are poor candidates for surgical or endovascular procedures require alternative treatment options that deliver improved long-term outcomes.

“We are excited that patients enrolled in our global CLI trial will begin to receive HemaTrate as treatment for this often-devastating condition.”

Based in Indianapolis, Cook Regentec is engaged in the development of next-generation technologies for the preparation and delivery of biologic and therapeutic agents

Cook Regentec is a business unit of Cook Group, which has a diverse business portfolio with companies working in life sciences, business services, resorts, property management and medical devices.

In July 2018, Cook Regentec reported the first clinical use of Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer to provide therapeutic to heart failure patients in the US.