Tuesday, July 25, 2006

Still no coverage of (ethical) spinal cord stem cells

Dr. Carlos Lima published his paper in the Journal of Spinal Cord Medicine last month on the treatment of patients with their own stem cells, derived from olfactory stem cells found in the nasal mucosa. These stem cells are easily obtained with minimal risk and reproduce readily, both in the body and in culture. In this case, intact mucosa was used, rather than isolated nerves and nerve progenitor or stem cells.


The patients are 7 of the over 60 patients that Dr. Lima has treated in his Lisbon, Portugal pilot trial. All of the patients in this report had chronic spinal cord traumatic lesions (over 6 months up to 78 months past injury, so that little if any spontaneous improvement could be expected), were followed for 18 months in 2001 to 2003. Each had surgery in which tissue containing the olfactory (or smelling) sensory nerve cells and the stem cells that allow the life-long regeneration of those sensory nerves.

6 of 7 patients had improved sensory function and all had some improvement in their motor function. 2 of the patients regained the ability to control their bladders and one, the control of his bowels. The levels of function were tested by a standardized scale before and after surgery.

This means that the transplanted cells either grew to function in the patients or stimulated the patient's spinal cord cells to grow and replace or bridge the gap made by the injury and the scar.


But where is the news coverage?

As reported earlier, the veterinarian from South Korea got at least 63 news articles yesterday covering the latest phase of his testimony on charges of embezzlement and misappropriation of funds that were meant to clone human embryos. Instead, the money was used to buy women's oocytes, clone a puppy, and in attempts to clone a tiger and a mammoth.


However, the formal report of the research with real results in humans, using their own stem cells as published in a peer-reviewed journal has received very little notice.



The Public Broadcasting System did cover the research and success in patients in a documentary in 2004.

"Miracle Cell" travels to Portugal to document on film, for the first time ever, the harvest and transplant operation. The film also tracks the progress of several of Dr. Lima's patients in the ensuing months. For some, improvement has been dramatic. As Dr. Hinderer assesses 19-year-old quadriplegic Laura Dominguez six months after her surgery, he concludes: "I've never seen recovery like this in 25 years of practice ... I can tell my patients they may walk again, rather than saying life from a wheel chair can be good." Two months later, Laura is able stand up on her toes and move her foot on command. Another of Dr. Lima's patients, paraplegic Joy Veron, is seen on the road to recovery after undergoing the treatment last August. Joy's injury is the result of a tragic accident in which she was run over by her SUV in an attempt to stop it from rolling off a cliff with her children inside. She began to experience some sensation in her leg almost immediately after surgery, and through intensive rehabilitation and fierce determination, Joy continues to make dramatic gains



News@nature.com (subscription only) included a short report on the study last December, in an article entitled, "Stem cell therapy or snake oil?"


"Whether you agree with it or not, it's happening," says Stephen Hinderer, a physiatrist at Detroit Medical Center. "To not learn from that doesn't make sense." For him, the solution is to identify good researchers abroad, and work with them to collect the safety data necessary to run a rigorous clinical trial in the US. One such pioneer is Carlos Lima based at the Hospital Egas Moniz in Lisbon (Box 1). Though Lima hasn't published, he has been perfecting his treatment for patients with spinal cord injuries, in which he implants a slice of autologous olfactory mucosa, which presumably contains a mixture of olfactory stem cells, a procedure approved by European regulatory authorities. Lima has operated on over 60 patients already, 16 from the Detroit Medical Center. Hinderer is seeking FDA approval to bring Lima's therapy to the US, and hopes the data will be convincing enough to skip straight to phase 2 trials in Detroit.

No comments: