We are pursuing growth opportunities for the use of the AutoloGel™ System in hair transplantation and the Angel® System in orthopedics, as well as actively seeking complementary products for wound care markets. Plans are underway to upgrade our AutoloGel™ System technology with the design of a new semi-closed blood separation device that will streamline the PRP process making the clinical procedure more efficient, reducing the margin of error and optimizing waste management.
Our Autologous Thrombin Processing Kit (ActivAT®) is designed to produce autologous thrombin serum from platelet poor plasma providing an autologous alternative to bovine-derived products. Thrombin is a blood coagulation factor that can facilitate blood clotting and platelet activation. The use of PPP to produce autologous thrombin avoids the loss of valuable PRP. The activAT® kit is sold exclusively in Europe and Canada, and ActivAT® is sold as an adjunct to the Angel®. It produces 5 to 6 ml of thrombin from 12 ml of PPP in approximately 30 minutes of processing time.
Strokes typically result in a loss of brain function due to a reduction in the blood supply to the brain.
Investigators have completed preclinical research in which a group of mice treated with ALD-401 two weeks after an induced stroke showed statistically significant improvement in motor function of 41% compared to the improvement of 11% in an untreated group. Researchers also saw statistically significant improvements in the slowing of decrease in brain volume and the reversal of decline in stroke-induced cell viability in the ALD-401 group compared to the untreated group. In another study, researchers assessed the amount of blood flow, or perfusion, in the brains of mice treated with ALDHbr cells two weeks after an induced stroke compared with mice treated only with a neutral delivery vehicle. Four weeks after the treatment, the brains of the mice that received the delivery vehicle remained impaired, but perfusion in the mice that had received ALDHbr cells had returned to normal levels.
A Phase 2 trial of ALD-401, the RECOVER-Stroke study, is underway.
Critical limb ischemia is characterized by impairment of blood flow to the legs and feet caused by blockage of the arteries.
In a 21-patient Phase 1/2 clinical trial, ALD-301 was well-tolerated, and we believe the trial data provided initial evidence of improved blood flow and improved clinical status within the ALD-301 treatment group. For example, at 12 weeks after treatment, four of the 11 patients treated in the ALD-301 treatment group experienced an improvement in the Rutherford category, which is a well-accepted clinical categorization for the extent of critical limb ischemia, to the degree that they were no longer classified as having critical limb ischemia. Critical limb ischemia patients with no revascularization options, such as those who participated in this trial, rarely experience improvements in Rutherford category. In addition, at 24 weeks after treatment, ten of the 11 patients in the ALD-301 treatment group were alive and had not required amputation of their affected limbs. Typically, up to 35% of critical limb ischemia patients with no revascularization options require an amputation within six months.
Ischemic heart failure is a result of poorly functioning heart muscle caused by reduced blood flow.
In a 20-patient Phase 1 clinical trial of ALD-201, the product candidate was well-tolerated and the trial provided initial evidence of improved blood flow and improved clinical status. The results showed a statistically significant reduction in ischemia in the ALD-201 treatment group as compared to a placebo group. In addition, after six months, the ALD-201 treatment group had a greater improvement in MaxVO2, a customary measure of the body’s ability to take up oxygen during exercise, than did the placebo group.
We supply ALDHbr cells for use in investigator-sponsored clinical studies that we expect will provide additional information about the mechanism of action of ALDHbr cells, effective routes of administration of these cells and product safety.
In a Phase 1 clinical trial, investigators at Duke treated patients with ALD-151, a population of ALDHbr cells produced by sorting cord blood, as an agent to possibly improve engraftment following cord blood transplants used to treat leukemia. See study details.
Investigators at Duke have commenced a Phase 1 clinical trial of ALD-601, a different formulation of ALDHbr cells sorted from cord blood, to treat inherited metabolic diseases through in utero stem cell transplantation. See study details.