Biocompatibles is pleased to announce that the Paul Ehrlich Institute, the regulatory agency of the German Ministry of Health, has granted permission for the start of a clinical trial for the treatment of patients immediately following a hemorrhagic stroke. Twenty patients will be treated with CellBeads, a product developed by Biocompatibles subsidiary CellMed, in a Phase I/II trial at the world-renowned International Neuroscience Institute (INI) in Hannover. The trial's primary end-point is safety; and data will be gathered on a number of indicators of efficacy.
Professor Thomas Brinker, the Principal Investigator, commented, "Progress in the development of new treatments for stroke has been painfully slow. The CellBeads technology is novel and the pre-clinical data is positive. We expect to recruit the first patient in the next few weeks.”
Every year approximately 125,000 people in the US and the five leading European countries suffer a hemorrhagic stroke and fewer than 40% live for more than 1 year, the lowest survival rate of any form of stroke. Only 20% of these survivors regain functional independence. The cascade of events starts with the sudden rupture of a blood vessel in the brain, causing hemorrhage and pressure inside the skull. Surgery is routinely used to relieve the pressure; but the hemorrhage causes a longer-term process of programmed cell death, orapoptosis, and it is this that causes the lasting neurological damage.
The CellBeads will be delivered directly to the injury site during the surgery. They are programmed to deliver CM1, a proprietary version of a naturally occurring protein, GLP-1, which has been shown to have powerful anti-apoptotic effects. The delivery mechanism is a cluster of adult stem cells encapsulated in alginate beads. The cells are programmed to produce the protein, which is delivered continuously, directly to the injury site. The alginate beads protect the stem cells from the body's immune system, which would otherwise destroy the foreign cells.
Products designed for the treatment of stroke have up until now been confounded by poor blood-brain permeability and half-lives measured in minutes. Professor Madjid Samii, Founder and President of the INI, commented, "I am very proud of INI's involvement with this exciting program. INI's unique focus on neuroscience has allowed us to play an active role in both the basic science and in clinical development."
Crispin Simon, Chief Executive of Biocompatibles, commented: "The CellBeads effectively create a local micro-factory, and I congratulate the CellMed-INI team on satisfying the regulators that such a radical approach is now ready for clinical evaluation. Stem cell science rightly attracts a lot of public interest and many different business models are emerging - including standardized products like ours, modifications of a patient's own cells, cord blood storage, and dedicated treatment clinics. The fundamental challenge for all these models is to show that the technology is safe and effective. That requires solid data from solid trials and is why today's announcement is so important for us."
Illustration: Intracerebral and intraventriclar hemorrhage. –Wikipedia.