A revolution looks like a real grind when you're up close and living it. Every little thing has to be done for the first time at seemingly great expense and endeavor, every new tool and technique built from scratch. Fast forward ten years and the first decade of this new century will look like a steep, rapid climb to new heights in hindsight - but working in the trenches today can be a matter of one step after the other.
Some articles illustrative of this theme today; compare where we are with where we'd like to be in our use of stem cells and knowledge and control of biochemistry. Fast doesn't always look like fast when you're the guy turning the crank.
The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US.
Geron’s product will have been tested in 2,000 animals before it goes into its first patient, Mr Okarma said. It consists of immature oligodendrocytes - specialised nerve cells - grown from human embryonic stem cells. The animal tests show that these can repair spinal cord injuries in rats, by growing new nerves with the myelin sheaths they need to work properly. Paralysed rats can walk again.
Mr Okarma said the product was designed to repair recent spinal damage and would need to be injected into patients within two weeks of the accident. It could not help people with long-term paralysis such as the late actor Christopher Reeve who did so much to champion stem cell research for spinal injury.
Amorcyte, Inc. (Amorcyte), a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, announced today the completion of the second of four dose cohorts in its phase I clinical trial.
The trial will now await review of the data by the data safety monitoring board (DSMB) in accordance with the protocol.
"All treatment patients in the second cohort received intra-coronary artery infusion of a specified number of stem cells. The DSMB will review the data on this second treatment group and determine whether to give approval to start accruing patients in the next cohort at an increased pre-specified number of stem cells infused", said Dr. Thomas Moss, Amorcyte's Chief Medical Officer.
From its dockside laboratories at Fells Point - once the settlement ‘‘stem” of Baltimore - Osiris Therapeutics Inc. has quietly grown into a leader in stem cell science and technology, with five treatments in clinical trials.
Osiris, with 120 employees, raised nearly $130 million in 2005 and 2006, through its initial public offering and several private financing rounds. It had sales of $9.5 million in 2006 from its only commercial product so far, Ostelocel for regenerating bone mass.
The company completed five clinical trials in 2006, leading to Phase 3 trials this year for treatments for Crohn’s Disease and a life-threatening condition called Graft vs. Host Disease, or GvHD, of some bone marrow transplant patients. Revenues for the fourth quarter ending Dec. 31, 2006 were $3.1 million compared with $1 million for the same period in 2005. Quarterly loss was $12.7 million compared with $8 million for fourth quarter 2005.
For all the promise, it's early days yet. Of course, a decade from now we'll be looking at similar hard work, trials and commercialization for the early stages of tissue engineering complete organs. Advancing biotechnology and medical research only looks slow and incremental if you stand up close to the workers.