Aldagen and Innovative Micro Technology (IMT) have formed an alliance to co-develop and commercialise a version of IMT's Rare Cell Purification System specifically for clinical cell therapies
This system, called the Aldesorter, will be used with Aldagen's Aldesort product and is designed to isolate unique stem cell populations for the treatment of chronic heart failure, peripheral vascular disease, leukemias, genetic enzyme deficiencies and other diseases.
The first Aldesorter is scheduled for completion in early 2007, with clinical trials planned to begin in late 2007.
Aldagen's Aldesort product is a set of proprietary reagents that can be used with currently available cell sorting systems to isolate a highly potent population of stem and progenitor cells from human bone marrow, peripheral blood and cord blood.
The unique chemistry incorporated into the Aldesort product allows the isolation of stem and progenitor cells based on the elevated expression of an intracellular enzyme, aldehyde dehydrogenase (ALDH).
Unlike currently available cell sorters that are large, complex research instruments, the Aldesorter is specifically designed to address the needs of clinical cell sorting including: ultra-high speed sorting, completely sealed fluidic path for disposability and sterility, compact size, and ease-of use.
When completed, the Aldesorter will be desk-top size and have the ability to sort therapeutic stem cell doses in one to three hours.
"With three clinical trials currently ongoing using Aldesort, we have recognised the need for a rapid and efficient cell sorting approach to allow optimal treatments for patients," said Tom Amick, chairman and CEO of Aldagen.
"IMT's cell purification technology is the most advanced in the world for clinical cell therapy applications and will broadly enable cellular treatments using our Aldesort product".
IMT is a contract manufacturer for Mems.
IMT will be responsible for the design and manufacture of the Aldesorter and the disposable Mems sorting chips.
Aldagen has expertise in the field of cellular therapy, and one of the top clinical development portfolios in the regenerative medicine field.
Aldagen is responsible for the cell labeling chemistries and for conducting clinical trials with the Aldesorter, as well as for marketing the Aldesorter system.
John Foster, CEO of IMT, stated: "It has always been IMT's goal to enable cell therapies for treatment of some of the most insidious human maladies.
"We are especially excited to be partnering with Aldagen, whose Aldesort product is being used in clinical trials today.
"We expect that the combination of Aldagen's and IMT's efforts will produce cell therapies that will make a very real and positive difference in peoples lives".
Aldagen currently has three clinical studies on-going using unique stem and progenitor cell populations identified with its Aldesort product.
These clinical studies are assessing the use of the populations in the treatment of ischemic heart failure, critical limb ischemia and pediatric cancer and genetic disorders.
There are currently 100,000s of patients in the United States that suffer from these conditions with few viable treatment options.
In addition, Aldagen believes these cell populations could be used to treat neural conditions (like ischemic stroke) and orthopedic conditions.
IMT was formed in 2000, specifically to produce Mems devices.
IMT's overriding goal is to partner with companies to develop products based on Mems technology.
Its 12,000m2 facility contains a 2700m2 clean room/fab, which it describes as the largest and best-equipped independent Mems fab in the world.
The company was built for high-volume manufacturing, and provides full Mems foundry and contract manufacturing services from design through production.
IMT currently has 150 employees and 20 customers in diverse applications, including drug discovery, drug delivery, biomedical implants and cell purifiers, microfluidics, inertial navigation, printing, various sensors, night vision, IR emitters, telephone/DSL switching, RF devices, power management, and several others.
Aldagen is a clinical-stage regenerative medicine company developing and commercialising products to treat vascular and degenerative diseases.
The company's proprietary products can identify and isolate potent, highly effective adult stem and progenitor cells which can be quickly administered to regenerate or repair tissue.
The company's lead product, Aldesort, is currently being tested at Texas Heart Institute and Duke University in three clinical studies for ischemic heart failure, critical limb ischemia and cord blood transplantation.
